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

Overview

To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2017

Interventions

  • Drug: OPC-41061

Arms, Groups and Cohorts

  • Experimental: OPC41061(15 mg) disintegrating tablet with water
    • OPC41061 (15 mg) orally disintegrating tablet is administered with water.
  • Experimental: OPC-41061(15 mg) disintegrating tablet without water
    • OPC41061 (15 mg) orally disintegrating tablet is administered without water.
  • Experimental: OPC-41061(15 mg) conventional tablet with water
    • OPC-41061 (15 mg) conventional tablet is administered with water.
  • Experimental: OPC41061(30 mg) disintegrating tablet with water
    • OPC41061 (30 mg) orally disintegrating tablet is administered with water.
  • Experimental: OPC-41061(30 mg) disintegrating tablet without water
    • OPC41061 (30 mg) orally disintegrating tablet is administered without water.
  • Experimental: OPC-41061(30 mg) conventional tablet with water
    • OPC-41061 (30 mg) conventional tablet is administered with water.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Plasma Concentration (Cmax) of Tolvaptan
    • Time Frame: 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.
  • Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 39 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hiroaki Ono, Mr, Study Director, Otsuka Pharmaceutical Co., Ltd.

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