NCT00973986

Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin

Study the Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin in Chinese Subjects With Coronary Heart Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Liuhuaqiao Hospital · Academic / Other
• Sex: Male
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the effects of CYP3A polymorphisms on the pharmacokinetics of Atorvastatin in Chinese subjects with coronary heart disease.

Detailed description

Large variability exists in the individual response to statins. CYP3A polymorphisms likely contribute to variable response to those drugs primarily metabolized by CYP3A including atorvastatin.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Atorvastatin	The subjects will receive atorvastatin (20 mg single dose) orally with approximately 240 ml of water. Blood samples(4 mL) will be taken prior to dosing and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24 and 48 h after drug administration.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2009-09-09
• Last updated: 2011-11-29

Locations

1 site across 1 country: China