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

Study Overview
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Brief Summary
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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
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Healthy Adult Male

Intervention / Treatment
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* Drug: OPC-41061


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC41061(15 mg) disintegrating tablet with water<br>OPC41061 (15 mg) orally disintegrating tablet is administered with water. | Drug: OPC-41061<br> <br> |
| Experimental: OPC-41061(15 mg) disintegrating tablet without water<br>OPC41061 (15 mg) orally disintegrating tablet is administered without water. | Drug: OPC-41061<br> <br> |
| Experimental: OPC-41061(15 mg) conventional tablet with water<br>OPC-41061 (15 mg) conventional tablet is administered with water. | Drug: OPC-41061<br> <br> |
| Experimental: OPC41061(30 mg) disintegrating tablet with water<br>OPC41061 (30 mg) orally disintegrating tablet is administered with water. | Drug: OPC-41061<br> <br> |
| Experimental: OPC-41061(30 mg) disintegrating tablet without water<br>OPC41061 (30 mg) orally disintegrating tablet is administered without water. | Drug: OPC-41061<br> <br> |
| Experimental: OPC-41061(30 mg) conventional tablet with water<br>OPC-41061 (30 mg) conventional tablet is administered with water. | Drug: OPC-41061<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of Tolvaptan | Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation. | Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose | 
| Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan | Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation. | Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose |