ASC-01

DRUG3 trials

Sponsors

Otsuka Pharmaceutical Co., Ltd.

Conditions

Healthy Male AdultsHealthy VolunteersMajor Depressive Disorder

Phase 1

A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects

CompletedNCT02088697

Otsuka Pharmaceutical Co., Ltd.Healthy Volunteers

Start: 2013-12-31End: 2014-01-31Updated: 2021-06-03

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

CompletedNCT03342963

Otsuka Pharmaceutical Co., Ltd.Healthy Male Adults

Start: 2017-11-21End: 2018-01-18Updated: 2021-05-03

Phase 3

Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder

CompletedNCT02046564

Otsuka Pharmaceutical Co., Ltd.Major Depressive Disorder

Start: 2014-02-28End: 2016-09-30Updated: 2018-05-21