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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Male Adults

Interventions

Type	Name	Description
DRUG	ASC-01	Aripiprazole 3 mg/sertraline 100 mg combination drug
DRUG	Aripiprazole and sertraline	Aripiprazole 3 mg and sertraline 100 mg

Timeline

• Start date: 2017-11-21
• Primary completion: 2018-01-18
• Completion: 2018-01-18
• First posted: 2017-11-17
• Last updated: 2021-05-03
• Results posted: 2021-05-03

Locations

1 site across 1 country: Japan