NCT01368783

Two Clinical Trials to Evaluate Pharmacokinetics of Unboosted and Boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and Caucasian volunteers and compare the ethnic differences.

Conditions

• Atazanavir

Interventions

Type	Name	Description
DRUG	atazanavir	400 mg/day for 2 days
DRUG	Atazanavir(ATZ) and Tenofovir(TDF)	ATZ 400 mg with TDF/day for 2 days
DRUG	Atazanavir(ATZ) + Ritonavir	ATZ 300 mg + Ritonavir 100 mg/day for 2 days
DRUG	atazanavir(ATZ) + tenofovir(TDF) + ritonavir	ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days

Timeline

• Start date: 2011-06-01
• First posted: 2011-06-08
• Last updated: 2011-06-08

Locations

1 site across 1 country: South Korea