NCT Number: NCT00991705
A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.
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Notify MeKey information
Age range
20 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Fimasartan
DrugSponsors and collaborators
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Oct 8, 2009
- Registry last updated
- Oct 8, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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