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A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

An Open-label, Two-treatment, Two-period, Two-sequence, Crossover Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00991705
Enrollment
28
Registered
2009-10-08
Start date
2009-07-31
Completion date
2009-09-30
Last updated
2009-10-08

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

Conditions

Essential Hypertension

Keywords

Fimasartan, Atorvastatin

Brief summary

The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.

Interventions

DRUGAtorvastatin
DRUGFimasartan

Sponsors

Boryung Pharmaceutical Co., Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* age: 20 - 45 years * sex: male * body weight: greater than 55 kg * written informed consent

Exclusion criteria

* known allergy to Fimasartan and atorvastatin * 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

Outcome results

None listed

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