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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASC-01 placebo

A single oral dose of ASC-01 Placebo (sertraline 100 mg)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Sertraline tablet

A single oral dose of sertraline tablets (sertraline 100 mg)

Group Type ACTIVE_COMPARATOR

ASC-01

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

ASC-01

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers aged 20 to 40 years.
* Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.

Exclusion Criteria

* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes