NCT00772551

Raltegravir and Ezetimibe PK Study

Evaluation of the Pharmacokinetics and Safety of Raltegravir and Ezetimibe When Co-administered to Male and Female Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: St Stephens Aids Trust · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when co-administered to male and female healthy volunteers.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Raltegravir and ezetimibe	Group 1: raltegravir 400 mg orally twice daily for 10 days followed by 10 days of raltegravir 400 mg twice daily and ezetimibe 10 mg orally once daily for 10 days followed by a 10 days wash out period and ezetimibe 10 mg once daily for 10 days
DRUG	Ezetimibe and raltegravir	Group2: ezetimibe 10 mg orally once daily for 10 days followed by ezetimibe 10 mg and raltegravir 400 mg orally twice daily for 10 days followed by a 10 days wash out period and raltegravir 400 mg twice daily for 10 days

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-10-15
• Last updated: 2010-08-16

Locations

1 site across 1 country: United Kingdom