A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

NCT ID: NCT02994394

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2017-02-28

Brief Summary

To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.

Conditions

Healthy Adult Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPC41061(15 mg) disintegrating tablet with water

OPC41061 (15 mg) orally disintegrating tablet is administered with water.

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

OPC-41061(15 mg) disintegrating tablet without water

OPC41061 (15 mg) orally disintegrating tablet is administered without water.

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

OPC-41061(15 mg) conventional tablet with water

OPC-41061 (15 mg) conventional tablet is administered with water.

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

OPC41061(30 mg) disintegrating tablet with water

OPC41061 (30 mg) orally disintegrating tablet is administered with water.

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

OPC-41061(30 mg) disintegrating tablet without water

OPC41061 (30 mg) orally disintegrating tablet is administered without water.

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

OPC-41061(30 mg) conventional tablet with water

OPC-41061 (30 mg) conventional tablet is administered with water.

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

Interventions

OPC-41061

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body weight of at least 50.0 kg
• BMI [body weight in kg / (height in m)2] of at least 17.6 kg/m2 and less than 25.0 kg/m2
• Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to the start of any trial-related procedures and capable of complying with the trial procedures for this study.

Exclusion Criteria

• Judged by the investigator,subinvestigator, or sponsor to have a clinically significant abnormality in results of the screening examination (including a notable deviation from the site's standard values) or a medical history that could place the subject at risk or affect the evaluation of drug absorption, distribution, metabolism, or excretion
• History of alcohol or drug dependence or abuse within 2 years prior to the trial
• History or current infection with hepatitis or acquired immunodeficiency syndrome (AIDS) or carrier of hepatitis B positive surface antigen (HBsAg), anti-hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis based on the results of the Treponema pallidum (TP) antibody test or rapid plasma reagin (RPR) test
• History of any severe drug allergy
• Positive results in alcohol screening test or urine drug screening test at time of screening examination or trial site admission
• Use of any other investigational medicinal product (IMP) within 120 days prior to Period 1 IMP administration
• Consumption of any food or beverage containing St. John's wort within 14 days prior to Period 1 IMP administration
• Consumption of any food or beverage containing grapefruit, Seville orange, or star fruit within 7 days prior to Period 1 IMP administration
• Judgment by the investigator or subinvestigator that the subject should not participate in the study for any other reason.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroaki Ono, Mr

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Kyusyu Region, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-163471

Identifier Type: OTHER

Identifier Source: secondary_id

156-102-00136

Identifier Type: -

Identifier Source: org_study_id