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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: OPC-41061

Study type: Interventional

Funder types: Industry

Identifiers

NCT02994394

JapicCTI-163471 (Other Identifier)

156-102-00136

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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84 participants in 6 patient groups

OPC41061(15 mg) disintegrating tablet with water

Experimental group

Description:

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

Treatment:

Drug: OPC-41061

OPC-41061(15 mg) disintegrating tablet without water

Experimental group

Description:

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

Treatment:

Drug: OPC-41061

OPC-41061(15 mg) conventional tablet with water

Experimental group

Description:

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

Treatment:

Drug: OPC-41061

OPC41061(30 mg) disintegrating tablet with water

Experimental group

Description:

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

Treatment:

Drug: OPC-41061

OPC-41061(30 mg) disintegrating tablet without water

Experimental group

Description:

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

Treatment:

Drug: OPC-41061

OPC-41061(30 mg) conventional tablet with water

Experimental group

Description:

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

Treatment:

Drug: OPC-41061