At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
sertraline hydrochloride +1 moredrug
Likely dose
sertraline hydrochloride 50 mgfrom 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.
Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioequivalence Study Comparing Sertraline Hydrochloride 50 mg Film-Coated Tablets To Sertraline Hydrochloride 50 mg Hard Capsules Under Fasted Conditions
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Nov 5, 2010·Updated Jan 27, 2021
In Brief
A Phase 1 clinical trial evaluating sertraline hydrochloride for Healthy. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSingapore
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedNov 2010
Primary CompletionDec 2010
TodayJul 2026
First PostedNov 5, 2010
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.7 years ago
Interventions
sertraline hydrochloridedrug
50 mg capsule, single-dose
sertraline hydrochloridedrug
50 mg tablet, single-dose