# 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

> **NCT03342963** · PHASE1 · COMPLETED · sponsor: **Otsuka Pharmaceutical Co., Ltd.** · enrollment: 74 (actual)

## Conditions studied

- Healthy Male Adults

## Interventions

- **DRUG:** ASC-01
- **DRUG:** Aripiprazole and sertraline

## Key facts

- **NCT ID:** NCT03342963
- **Lead sponsor:** Otsuka Pharmaceutical Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-11-21
- **Primary completion:** 2018-01-18
- **Final completion:** 2018-01-18
- **Target enrollment:** 74 (ACTUAL)
- **Last updated:** 2021-05-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03342963

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03342963, "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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03342963. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
