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

NCT02088697 | Completed Phase 1 Results

• 1 other identifier: 031-13-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax) of Sertraline

  predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose

Secondary Outcomes (1)

• Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline

  predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose

Study Arms (2)

ASC-01 placebo

EXPERIMENTAL

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

Drug: Placebo

Sertraline tablet

ACTIVE COMPARATOR

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

Drug: ASC-01

Interventions

Placebo DRUG

ASC-01 placebo

ASC-01 DRUG

Sertraline tablet

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Osaka Pharmacology Clinical research Hospital

Osaka, Japan

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 17, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 3, 2021
• Results First Posted: June 3, 2021

Record last verified: 2021-05

Locations

JP (1)