CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 74 enrolled
Drug / intervention
ASC-01 +1 moredrug
Likely dose
ASC-01 3 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.

Search/NCT03342963
NCT03342963Phase 1Completed
CompareCT.gov

A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Nov 17, 2017·Updated May 3, 2021

In Brief

A Phase 1 clinical trial evaluating ASC-01 and Aripiprazole and sertraline for Healthy Male Adults. Completed, enrolled 74 participants across 1 site.

Detailed Summary

To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1). To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Male Adults
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartNov 21, 2017
Primary CompletionJan 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.6 years ago

Interventions

ASC-01drug

Aripiprazole 3 mg/sertraline 100 mg combination drug

Aripiprazole and sertralinedrug

Aripiprazole 3 mg and sertraline 100 mg