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Trial record 76 of 854 for:    tablet | Japan

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

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ClinicalTrials.gov Identifier: NCT02994394
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Adult Male Drug: OPC-41061 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: OPC41061(15 mg) disintegrating tablet with water
OPC41061 (15 mg) orally disintegrating tablet is administered with water.
Drug: OPC-41061
Experimental: OPC-41061(15 mg) disintegrating tablet without water
OPC41061 (15 mg) orally disintegrating tablet is administered without water.
Drug: OPC-41061
Experimental: OPC-41061(15 mg) conventional tablet with water
OPC-41061 (15 mg) conventional tablet is administered with water.
Drug: OPC-41061
Experimental: OPC41061(30 mg) disintegrating tablet with water
OPC41061 (30 mg) orally disintegrating tablet is administered with water.
Drug: OPC-41061
Experimental: OPC-41061(30 mg) disintegrating tablet without water
OPC41061 (30 mg) orally disintegrating tablet is administered without water.
Drug: OPC-41061
Experimental: OPC-41061(30 mg) conventional tablet with water
OPC-41061 (30 mg) conventional tablet is administered with water.
Drug: OPC-41061



Primary Outcome Measures :
  1. Measure the Maximum (Peak) plasma concentration of the drug (Cmax) [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hour Post-dose ]
  2. Measure the Time to maximum (Peak) plasma concentration (AUC) [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hour Post-dose ]


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994394


Locations
Japan
Kyusyu region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02994394     History of Changes
Other Study ID Numbers: 156-102-00136
JapicCTI-163471 ( Other Identifier: Japic )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs