A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers

Essential Hypertension Clinical Trial

Official title:

A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938132
• Other study ID #: A657-BR-CT-108
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2009
• Last updated: October 7, 2009
• Start date: July 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• age: 20 - 40 years

• sex: male

• body weight: greater than 55 kg

• written informed consent

Exclusion Criteria:

• known allergy to Fimasartan and warfarin

• existing cardiac or hematological diseases

• existing hepatic and renal diseases

• existing gastrointestinal diseases

• acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder

• positive drug or alcohol screening

• smokers of 10 or more cigarettes per day 3 month ago

• participation in a clinical trial during the last 2 months prior to the start of the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• fimasartan, warfarin
Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INR AUC, INRmax, INRtmax		pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d	Yes
Secondary	AUClast, AUCinf, Cmax ,Tmax, CL/F of S-warfarin and R-warfarin		pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d	Yes