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

Phase 1

Completed

• Conditions: Healthy adult male

• Registration Number: JPRN-jRCT1080223416
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

The bioequivalence of tolvaptan OD tablets and tolvaptan conventional tablet in 15 and 30 mg was demonstrated. There were no safety concerns with either formulation in 2 dosing regimens.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-19
• Study Completion: 2017-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 84

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified