Healthy adult male
Conditions
Interventions
investigational material(s)
Generic name etc : Tolvaptan OD tablet
INN of investigational material : Tolvaptan
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational m
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bioequivalence AUCt and Cmax of tolvaptan | — |
Countries
Japan
Outcome results
None listed