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drugset / Trial / NCT03734354

The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects

NCT03734354 ↗

Phase 1 Completed 30 enrolled Otsuka Beijing Research Institute
RandomizedParallel-groupOpen-labelOther

Summary

This study is a single-center, open-label study evaluating the pharmacokinetics, tolerability and safety of single dose oral brexpiprazole tablets in healthy Chinese subjects. A total of 30 healthy adult subjects are to be enrolled into the study. Three dose groups will be set up, with about 10 subjects in each dose group. Subjects will enter 1 mg, 2 mg and 4 mg dose groups in sequence.

Timeline

Start
2019-04-07
Primary completion
2020-05-18
Completion
2020-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Brexpiprazole Small molecule 1 mg Oral
Subject Brexpiprazole Small molecule 2 mg Oral
Subject Brexpiprazole Small molecule 4 mg Oral

Indications

No indication recorded.