Pharmacokinetics/Pharmacodynamics (PK/PD) Characteristics of Tolvaptan Tablet in Korean Healthy Male

NCT ID: NCT01014416

Last Updated: 2010-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-03-31

Brief Summary

To investigate the safety, tolerance, pharmacokinetics and pharmacodynamics of tolvaptan 15, 30 and 60 mg after single oral administration in healthy Korean male subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Single dose, Tolvaptan 15mg or Placebo/day

Group Type: EXPERIMENTAL

Tolvaptan 15mg or 30mg or 60mg or Placebo

Intervention Type: DRUG

Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

Arm 2

Single dose, Tolvaptan 30mg or Placebo/day

Group Type: EXPERIMENTAL

Tolvaptan 15mg or 30mg or 60mg or Placebo

Intervention Type: DRUG

Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

Arm 3

Single dose, Tolvaptan 60mg or Placebo/day

Group Type: EXPERIMENTAL

Tolvaptan 15mg or 30mg or 60mg or Placebo

Intervention Type: DRUG

Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

Interventions

Tolvaptan 15mg or 30mg or 60mg or Placebo

Single dose of Tolvaptan 15mg or 30mg or 60mg or Placebo per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy Korean male subjects between 20 and 45 years of age, inclusive.

2. Body Mass Index (BMI) of 20 to 26 kg/m2, body,weight ≥ 50kg BMI = weight (kg)/height2(m)

3. Informed consent from the subjects

Exclusion Criteria

1. Clinically significant abnormality of respiratory, cardiovascular, hepatic, neurologic, endocrine, hematologic, urinary, psychiatric.

2. History of gastrointestinal disease or surgery which can affect intestinal absorption of the study drug.

3. History of any significant drug allergy or hypersensitivity.

4. AST or ALT > 1.25 times upper normal limit at screening clinical laboratory test

5. Supine blood pressure after resting for ≥ 3 minutes, higher than 140/90 mmHg or lower than 100/50 mmHg, Supine pulse, after resting for ≥ 3 minutes, outside the range of 40 to 90 beats/minute.

6. Subjects who had history of drug abuse or alcohol addiction

7. Subjects who used of any prescription drug or herbal medication within 2 weeks prior to the first dosing of the study drug, or any over-the-counter or vitamin supplements within 1 week prior to the first dosing (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied)

8. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Korea Otsuka Pharmaceutical Co.,Ltd.

Principal Investigators

Kyung-Sang Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

156-KOA-0801

Identifier Type: -

Identifier Source: org_study_id