{"protocolSection":{"identificationModule":{"nctId":"NCT01367080","orgStudyIdInfo":{"id":"DWETR-I-1"},"organization":{"fullName":"Dong Wha Pharmaceutical Co. Ltd.","class":"INDUSTRY"},"briefTitle":"A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg","officialTitle":"Clinical Trials to Compare the Pharmacokinetics Profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg After a Single Oral Administration in Healthy Male Volunteers","acronym":"DWETR"},"statusModule":{"statusVerifiedDate":"2014-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-07"},"primaryCompletionDateStruct":{"date":"2011-08","type":"ACTUAL"},"completionDateStruct":{"date":"2011-09","type":"ACTUAL"},"studyFirstSubmitDate":"2011-06-02","studyFirstSubmitQcDate":"2011-06-03","studyFirstPostDateStruct":{"date":"2011-06-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-02-20","resultsFirstSubmitQcDate":"2014-08-06","resultsFirstPostDateStruct":{"date":"2014-08-22","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-08-06","lastUpdatePostDateStruct":{"date":"2014-08-22","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Dong Wha Pharmaceutical Co. Ltd.","class":"INDUSTRY"},"collaborators":[{"name":"Chonbuk National University Hospital","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \\& 25mg","detailedDescription":"Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers"},"conditionsModule":{"conditions":["Depression","Depressive State","Enuresis"],"keywords":["depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":12,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"A Group","type":"EXPERIMENTAL","description":"1. 1st administration - DWETR10\n2. 2nd administration - DWETR25","interventionNames":["Drug: DWETR10","Drug: DWETR25"]},{"label":"B Group","type":"EXPERIMENTAL","description":"1. 1st administration - DWETR25\n2. 2nd administration - DWETR10","interventionNames":["Drug: DWETR10","Drug: DWETR25"]}],"interventions":[{"type":"DRUG","name":"DWETR10","description":"Amitriptyline hydrochloride 10mg(DWETR10) single dose","armGroupLabels":["A Group","B Group"],"otherNames":["Etravil 10mg"]},{"type":"DRUG","name":"DWETR25","description":"Amitriptyline hydrochloride 25mg(DWETR25) single dose","armGroupLabels":["A Group","B Group"],"otherNames":["Etravil 25mg"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"AUClast and AUCinf","description":"Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma","timeFrame":"Up to 72 hours"}],"secondaryOutcomes":[{"measure":"Cmax","description":"Maximum Concentration(Cmax) of amitryptyline in plasma","timeFrame":"Up to 72 hours"},{"measure":"Tmax","description":"Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma","timeFrame":"Up to 72 hours"},{"measure":"t1/2","description":"Terminal half-time(t1/2) of Amitryptyline in Plasma","timeFrame":"Up to 72 hours"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* a healthy adult male within the range of 19 to 50 years old at the time of screening\n* one with weight of more than 55kg, in the range of IBW 20%\n\n  * Ideal Body Weight(IBW)(kg)={height(cm)-100}\\*0.9\n* one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol.\n\nExclusion Criteria:\n\n* one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history\n* one with glaucoma\n* one with disorders of micturition include benign prostatic hyperplasia\n* one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.\n* one who is allergic or has clinically significant allergic history to the study drug, components or tricyclic antidepressants(TCA)\n* one who shows the following result in vital sign: hypotension(systolic pressure ≤ 100mmHg or diastolic pressure ≤ 65mmHg) or hypertension(systolic pressure ≥ 150mmHg or diastolic pressure ≥ 95mmHg)\n* one who has drug abuse history\n* one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)\n* one who has participated in other clinical study within 2 months before study drug administration\n* one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment\n* one who drank Over 21 units/week of alcohol(1 unit = 10g of pure alcohol) or subjects who would not be able to stop drinking alcohol during the hospitalization\n* one who are heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization\n* one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization\n* one with clinically significant observations considered as unsuitable based on medical judgment by investigators","healthyVolunteers":true,"sex":"MALE","minimumAge":"19 Years","maximumAge":"50 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Min-Gul Kim, MD, PhD","affiliation":"Chonbuk National University Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Chonbuk National University Hospital.","city":"Jeonju","state":"Jeollabuk-do","zip":"561-712","country":"South Korea","geoPoint":{"lat":35.82194,"lon":127.14889}}]},"referencesModule":{"references":[{"pmid":"25308868","type":"DERIVED","citation":"Nam Y, Lim CH, Lee HS, Chung SJ, Chung YH, Shin YK, Kim MG, Sohn UD, Kim HC, Jeong JH. Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10- and 25-mg tablet in healthy male Korean volunteers. Clin Ther. 2015 Feb 1;37(2):302-10. doi: 10.1016/j.clinthera.2014.09.010. Epub 2014 Oct 11."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"15 participants recruited ; 12 screened, 3 excluded (2 did not meet inclusion criteria and 1 refused participation)","recruitmentDetails":"Participants recruited from a specialty clinic at a hospital, Korea between July 2011 and August 2011","groups":[{"id":"FG000","title":"A Group","description":"Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)"},{"id":"FG001","title":"B Group","description":"Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)"}],"periods":[{"title":"1st Administration","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"2nd Administration","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"A Group","description":"Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)"},{"id":"BG001","title":"B Group","description":"Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.2","spread":"2.1"},{"groupId":"BG001","value":"21.2","spread":"2.1"},{"groupId":"BG002","value":"21.7","spread":"1.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Korea, Republic of","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"AUClast and AUCinf","description":"Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Up to 72 hours","groups":[{"id":"OG000","title":"Etravil 10mg Group","description":"Amitryptiline Hydrochloride 10mg administration Group"},{"id":"OG001","title":"Etravil 25mg Group","description":"Amitryptiline hydrochloride 25mg administration Group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"title":"AUClast","categories":[{"measurements":[{"groupId":"OG000","value":"91.35","spread":"25.88"},{"groupId":"OG001","value":"260.68","spread":"111.57"}]}]},{"title":"AUCinf","categories":[{"measurements":[{"groupId":"OG000","value":"109.74","spread":"37.80"},{"groupId":"OG001","value":"296.87","spread":"124.99"}]}]}]},{"type":"SECONDARY","title":"Cmax","description":"Maximum Concentration(Cmax) of amitryptyline in plasma","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Up to 72 hours","groups":[{"id":"OG000","title":"Etravil 10mg Group","description":"Amitryptiline Hydrochloride 10mg Administration Group"},{"id":"OG001","title":"Etravil 25mg Group","description":"Amitryptiline Hydrochloride 25mg Administration Group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.96","spread":"1.40"},{"groupId":"OG001","value":"17.69","spread":"5.27"}]}]}]},{"type":"SECONDARY","title":"Tmax","description":"Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"Up to 72 hours","groups":[{"id":"OG000","title":"Etravil 10mg Group","description":"Amitryptiline Hydrochloride 10mg Administration Group"},{"id":"OG001","title":"Etravil 25mg Group","description":"Amitryptiline Hydrochloride 25mg Administration Group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.50","spread":"0.90"},{"groupId":"OG001","value":"3.13","spread":"0.61"}]}]}]},{"type":"SECONDARY","title":"t1/2","description":"Terminal half-time(t1/2) of Amitryptyline in Plasma","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"Up to 72 hours","groups":[{"id":"OG000","title":"Etravil 10mg Group","description":"Amitryptiline Hydrochloride 10mg Administration Group"},{"id":"OG001","title":"Etravil 25mg Group","description":"Amitryptiline Hydrochloride 25mg Administration Group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.47","spread":"5.64"},{"groupId":"OG001","value":"24.79","spread":"3.22"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"About a month","eventGroups":[{"id":"EG000","title":"Etravil 10mg Group","description":"Amitryptyline hydrochloride 10mg administration Group","seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":2,"otherNumAtRisk":12},{"id":"EG001","title":"Etravil 25mg Group","description":"Amitryptyline hydrochloride 25mg administration Group","seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":2,"otherNumAtRisk":12}],"otherEvents":[{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":12},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":12}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 13.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":12},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":12}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"When collecting blood samples, few subjects were drawn blood later than that stated in protocol for about 1 \\~ 2 minutes where results may not be effected.\n\nOne of the subjects came in late for Post-study visit for about 4\\~6 days."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Cheol-Hee Lim. Clinical Research Manager (CRM)","organization":"Dong Wha Pharm. Co. Ltd.","email":"cheolhee.lim@dong-wha.co.kr","phone":"+82-2-2021-9300","phoneExt":"551"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"},{"id":"D004775","term":"Enuresis"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D014555","term":"Urination Disorders"},{"id":"D014570","term":"Urologic Diseases"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D019960","term":"Elimination Disorders"},{"id":"D001523","term":"Mental Disorders"}]}},"hasResults":true}