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

A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalation Study to Investigate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Tolvaptan in Healthy Korean Male Subjects Bipolar Disorder

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01014416

Enrollment

Registered

2009-11-17

Start date

2010-01-31

Completion date

2010-03-31

Last updated

2010-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Korean male

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.

Interventions

DRUGTolvaptan 15mg or 30mg or 60mg or Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
PK parameters: AUC, Cmax, Tmax	1 day
PD parameters: 24 hour fluid balance	1 day
Safety: adverse event, body weight, physical examination, vital sign, ECG, clinical laboratory test	4 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026