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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 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-06-08

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30

Countries

  • South Korea

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01368783 on ClinicalTrials.gov