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Bioequivalence and food-effect study of ASC-01 vs separate aripiprazole + sertraline in healthy males
jRCT2080223718Phase 1Completed
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Start
- Nov 2017
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of aripiprazole + sertraline, aripiprazole and sertraline (4 cohorts), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoints: Primary pharmacokinetic endpoints for aripiprazole bioequivalence and Food-effect pharmacokinetic endpoints for ASC-01. Started Nov 2017; status: completed.
02
Drugs
aripiprazole + sertralinearipiprazolesertraline
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