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

Healthy Adult Male Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994394
• Other study ID #: 156-102-00136
• Secondary ID: JapicCTI-163471
• Status: Completed
• Phase: Phase 1
• Start date: January 6, 2017
• Est. completion date: February 28, 2017

Study information

• Verified date: June 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Male

Intervention

Drug:
• OPC-41061

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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