drugset / Trial / 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

NCT01368783

RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2011-06
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified 300 mg
Subject Atazanavir Other / unclassified 400 mg
Subject Ritonavir Other / unclassified 100 mg
Subject Tenofovir Small molecule

Indications

No indication recorded.