Bioequivalence study of OPC-41061 1% powder-formulation

JRCT ID: jRCT1080222790

Registered date:11/03/2015

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Volume overload in heart failure
• Date of first enrollment: 14/08/2014
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : OPC-41061 1% powder
INN of investigational material : Tolvaptan
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational material : Single oral administration with about 150 mL of water after fasting

control material(s)
Generic name etc : OPC-41061 15 mg tablet
INN of investigational material : Tolvaptan
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational material : Single oral administration with about 150 mL of water after fasting

Outcome(s)

Primary Outcome

bioequivalence
AUCt and Cmax of OPC-41061
The difference in the mean log-transformed values between the two formulations and the 90% CI are determined.

Secondary Outcome

bioequivalence
1)Plasma concentration-time profile of OPC-41061
2)AUC, MRT, tmax, Lambdaz of OPC-41061

The data are log-transformed and examined by ANOVA using the group, formulation, subject within group, and administration period as factors.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 39age old
• Gender: Male

Include criteria

1)Judged to be capable of providing written informed consent prior to the start of the examinations for this study
2)Body weight of at least 50.0 kg
3)BMI [body weight in kg / (height in m)2]: At least 17.6 kg/m2 and less than 25.0 kg/m2
4)Judged to be healthy based on medical history, physical findings, vital signs, 12-lead ECG, clinical laboratory findings, etc
5)Subjects who, together with their partner(s), are capable of using an effective method of contraception from the time of written informed consent until 90 days after final investigational medicinal product (IMP) administration

Exclude criteria

1)Abnormality that could place the subject at risk or affect drug absorption, distribution, metabolism, or excretion; includes history or current symptoms of cardiac, hepatic, renal, neurological, endocrine, gastrointestinal, respiratory, hematological, or immunological disease
2)History of alcohol or drug dependence or abuse
3)Suspected infection with hepatitis B, hepatitis C, HIV, or syphilis based on results of the respective tests
4)History of any drug allergy (including all prescription and OTC drugs)
5)Urine alcohol test result of 0.1 mg/mL or more or positive result for urine drug screening
6)History of difficulty in blood collection
7)Administration of any investigational drug within 120 days prior to Period 1 IMP administration
8)Blood collection (blood donation, etc) of more than 200 mL within 30 days, more than 400 mL within 90 days, or 1200 mL or more within 1 year prior to Period 1 IMP administration
9)Consumption of any food or beverage containing St. John's wort within 14 days prior to Period 1 IMP administration
10)Consumption of any food or beverage containing grapefruit, Seville orange, or star fruit within 7 days prior to Period 1 IMP administration
11)Use of any prescription or OTC drug within 14 days prior to Period 1 IMP administration
12)Smoking or positive result for urine cotinine test within 60 days prior to Period 1 IMP administration
13)Occupational exposure to pesticides or organic solvents within 30 days prior to screening
14)Blood pressure after 3 minutes of rest outside the normal range at the study site
15)Heart rate after 3 minutes of rest outside the normal range at the study site
16)History of bleeding or bleeding tendency
17)No fixed address
18)History of any serious psychiatric disorder judged inappropriate for inclusion in the study

Related Information

• Primary Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): JapicCTI-152842