A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
- Registration Number
- NCT02994394
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
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
- CROSSOVER
- Arm && Interventions
Group Intervention Description OPC41061(15 mg) disintegrating tablet with water OPC-41061 OPC41061 (15 mg) orally disintegrating tablet is administered with water. OPC-41061(15 mg) disintegrating tablet without water OPC-41061 OPC41061 (15 mg) orally disintegrating tablet is administered without water. OPC-41061(30 mg) disintegrating tablet without water OPC-41061 OPC41061 (30 mg) orally disintegrating tablet is administered without water. OPC-41061(30 mg) conventional tablet with water OPC-41061 OPC-41061 (30 mg) conventional tablet is administered with water. OPC-41061(15 mg) conventional tablet with water OPC-41061 OPC-41061 (15 mg) conventional tablet is administered with water. OPC41061(30 mg) disintegrating tablet with water OPC-41061 OPC41061 (30 mg) orally disintegrating tablet is administered with water.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose 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.
Maximum Plasma Concentration (Cmax) of Tolvaptan Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose 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.
- Secondary Outcome Measures
Name Time Method