{"protocolSection":{"identificationModule":{"nctId":"NCT02078180","orgStudyIdInfo":{"id":"HHSF223201310164C"},"secondaryIdInfos":[{"id":"HUM00081894","type":"OTHER","domain":"UM IRBMED"}],"organization":{"fullName":"University of Michigan","class":"OTHER"},"briefTitle":"Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns","officialTitle":"Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns"},"statusModule":{"statusVerifiedDate":"2017-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-04"},"primaryCompletionDateStruct":{"date":"2016-11","type":"ACTUAL"},"completionDateStruct":{"date":"2016-11","type":"ACTUAL"},"studyFirstSubmitDate":"2014-02-28","studyFirstSubmitQcDate":"2014-03-04","studyFirstPostDateStruct":{"date":"2014-03-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-07-11","resultsFirstSubmitQcDate":"2017-09-01","resultsFirstPostDateStruct":{"date":"2017-10-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-09-01","lastUpdatePostDateStruct":{"date":"2017-10-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Duxin Sun","investigatorTitle":"Professor of Pharmaceutical Sciences","investigatorAffiliation":"University of Michigan"},"leadSponsor":{"name":"University of Michigan","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The objectives of this project are to determine if the bioavailability and release pattern of bupropion HCl products differ and if the genotype of the metabolic enzymes affects the saturation of intestinal enzymes with different dose strengths within one product line. Findings from this project will help the FDA Center for Drug Evaluation and Research's (CDER) Office of Generic Drugs improve policy development and review practice in the future for similar products, e.g. extended release oral drug products being metabolized in the gut wall and having multiple strengths.\n\nAim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy individuals when they ingest different strengths of bupropion (75-300 mg) with variable release profiles (IR vs XL vs SR) in GI tract.\n\nWorking hypothesis: Variation in release rate and mechanism of bupropion formulations in gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract, which will generate different concentration of bupropion and its metabolites in plasma.\n\nAim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and pharmacokinetics of bupropion\n\nWorking hypothesis: The gain of function of CYP2B6 variants (allele \\*4 and \\*22) in patients will increase the metabolism of bupropion in the GI tract and liver, reduce both local concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when bupropion is released earlier in GI tract"},"conditionsModule":{"conditions":["Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":34,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"generic bupropion IR75","type":"ACTIVE_COMPARATOR","description":"One oral dose of generic bupropion IR75","interventionNames":["Drug: generic bupropion"]},{"label":"generic bupropion IR100","type":"ACTIVE_COMPARATOR","description":"One oral dose of generic bupropion IR100","interventionNames":["Drug: generic bupropion"]},{"label":"generic bupropion SR100","type":"ACTIVE_COMPARATOR","description":"One oral dose of generic bupropion SR100","interventionNames":["Drug: generic bupropion"]},{"label":"generic bupropion SR150","type":"ACTIVE_COMPARATOR","description":"One oral dose of generic bupropion SR150","interventionNames":["Drug: generic bupropion"]},{"label":"generic bupropion XL150","type":"ACTIVE_COMPARATOR","description":"One oral dose of generic bupropion XL150","interventionNames":["Drug: generic bupropion"]},{"label":"generic bupropion XL300","type":"ACTIVE_COMPARATOR","description":"One oral dose of generic bupropion XL300","interventionNames":["Drug: generic bupropion"]}],"interventions":[{"type":"DRUG","name":"generic bupropion","description":"We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.","armGroupLabels":["generic bupropion IR100","generic bupropion IR75","generic bupropion SR100","generic bupropion SR150","generic bupropion XL150","generic bupropion XL300"],"otherNames":["Wellbutrin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage","description":"Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).","timeFrame":"4 days"}],"secondaryOutcomes":[{"measure":"Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage","description":"Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the maximum concentration. The maximum concentration depends on the rate of drug release and so looking at this value can help us compare differences between formulation.","timeFrame":"4 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy volunteers 25 to 55 years old.\n* Volunteers have a Body Mass Index (BMI), calculated from the ratio of height and weight, within a range of 18.5 to 35.\n* Willing to be medication and supplement free 2 weeks prior to beginning study, and throughout the study. All forms of birth control are okay.\n\nExclusion Criteria:\n\n* Individuals unwilling or unable to comply with the study protocol (e.g. unable to remain medication or supplement free during the study).\n* Individuals unwilling or unable to take bupropion or have an allergy to bupropion\n* Any medical or surgical conditions which might significantly alter bupropion absorption (e.g., history of malabsorption, liver disease, gastric bypass surgery )\n* Individuals with a history of psychiatric or neurological illness, including seizure disorders\n* Nicotine dependence\n* Alcohol dependence\n* Pregnant or nursing women","healthyVolunteers":true,"sex":"ALL","minimumAge":"25 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Duxin Sun, PhD","affiliation":"University of Michigan","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","zip":"48109-2700","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"IR75, IR200, SR100, SR150, XL150, XL300","description":"Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"34"}]},{"type":"IR75","achievements":[{"groupId":"FG000","numSubjects":"30"}]},{"type":"IR100","achievements":[{"groupId":"FG000","numSubjects":"31"}]},{"type":"SR100","achievements":[{"groupId":"FG000","numSubjects":"31"}]},{"type":"SR150","achievements":[{"groupId":"FG000","numSubjects":"32"}]},{"type":"XL 150","achievements":[{"groupId":"FG000","numSubjects":"31"}]},{"type":"XL 300","achievements":[{"groupId":"FG000","numSubjects":"32"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300","description":"Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"34"}]}],"measures":[{"title":"Age, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"<25 years","categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}]},{"title":"25-65 years","categories":[{"measurements":[{"groupId":"BG000","value":"34"}]}]},{"title":">65 years","categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"18"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"16"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"24"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage","description":"Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"h*nanogram/milliliter","timeFrame":"4 days","groups":[{"id":"OG000","title":"Generic Bupropion IR75","description":"One oral dose of generic bupropion IR75\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG001","title":"Generic Bupropion IR100","description":"One oral dose of generic bupropion IR100\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG002","title":"Generic Bupropion SR100","description":"One oral dose of generic bupropion SR100\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG003","title":"Generic Bupropion SR150","description":"One oral dose of generic bupropion SR150\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG004","title":"Generic Bupropion XL150","description":"One oral dose of generic bupropion XL150\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG005","title":"Generic Bupropion XL300","description":"One oral dose of generic bupropion XL300\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"30"},{"groupId":"OG003","value":"32"},{"groupId":"OG004","value":"30"},{"groupId":"OG005","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"469","spread":"177"},{"groupId":"OG001","value":"667","spread":"418"},{"groupId":"OG002","value":"706","spread":"304"},{"groupId":"OG003","value":"1002","spread":"516"},{"groupId":"OG004","value":"740","spread":"449"},{"groupId":"OG005","value":"1356","spread":"637"}]}]}]},{"type":"SECONDARY","title":"Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage","description":"Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the maximum concentration. The maximum concentration depends on the rate of drug release and so looking at this value can help us compare differences between formulation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"nanogram/milliliter","timeFrame":"4 days","groups":[{"id":"OG000","title":"Generic Bupropion IR75","description":"One oral dose of generic bupropion IR75\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG001","title":"Generic Bupropion IR100","description":"One oral dose of generic bupropion IR100\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG002","title":"Generic Bupropion SR100","description":"One oral dose of generic bupropion SR100\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG003","title":"Generic Bupropion SR150","description":"One oral dose of generic bupropion SR150\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG004","title":"Generic Bupropion XL150","description":"One oral dose of generic bupropion XL150\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."},{"id":"OG005","title":"Generic Bupropion XL300","description":"One oral dose of generic bupropion XL300\n\ngeneric bupropion: We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"30"},{"groupId":"OG003","value":"32"},{"groupId":"OG004","value":"30"},{"groupId":"OG005","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93","spread":"36"},{"groupId":"OG001","value":"136","spread":"70"},{"groupId":"OG002","value":"61","spread":"29"},{"groupId":"OG003","value":"78","spread":"40"},{"groupId":"OG004","value":"61","spread":"34"},{"groupId":"OG005","value":"111","spread":"44"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Varied per person from 3 months to 10 months based on their randomization sequence and the time that it took to complete all phases of the study with washout between each formulation.","eventGroups":[{"id":"EG000","title":"IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300","description":"Participants were randomized to receive one pill each of IR 75, IR 100, SR 100, SR 150, XL 150 and XL 300,in randomized order at six time points. Given the large number of possible sequence combinations, participants are reported as a single Participant Flow Arm with Milestones used to indicate how many participants received each intervention","deathsNumAffected":0,"deathsNumAtRisk":34,"seriousNumAffected":0,"seriousNumAtRisk":34,"otherNumAffected":10,"otherNumAtRisk":34}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":34}]},{"term":"Peripheral vision loss","organSystem":"Eye disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Briefly experienced loss of peripheral vision in right eye for approximately 30 minutes 6 days after dose. Full vision came back and participant did not experience anything out of the ordinary before or since resolution of vision loss.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":34}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":34}]},{"term":"Dizzyness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":34}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Rash on both arms following completion of phase six of the study. Rash was located near site of blood draws on arms.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":34}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The small study sample size may have masked the contribution of pharmacogenetics to bupropion metabolism."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Duxin Sun","organization":"University of Michigan","email":"pharmacy.research@umich.edu","phone":"734-763-9783"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}