At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
DWETR10 +1 moredrug
Likely dose
DWETR10 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating DWETR10 and DWETR25 for Depression and 2 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Depressive State, Enuresis
CountriesSouth Korea
CollaboratorsChonbuk National University Hospital
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJul 2011
Primary CompletionAug 2011
Study CompletionSep 2011
TodayJul 2026
First PostedJun 6, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.1 years ago
Interventions
DWETR10drug
Amitriptyline hydrochloride 10mg(DWETR10) single dose
DWETR25drug
Amitriptyline hydrochloride 25mg(DWETR25) single dose