Atazanavir Twice Daily

Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00357721

Enrollment

Registered

2006-07-27

Start date

2006-06-30

Completion date

2006-09-30

Last updated

2011-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Protease Inhibitor

Brief summary

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

Interventions

DRUGAtazanavir Sulphate

Capsules, Oral, 200 mg, twice daily, 7 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2

Design outcomes

Primary

Measure	Time frame
Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.	—

Secondary

Measure	Time frame
Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID	—
Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform	—
Assess the effect of atazanavir BID on metabolic parameters	—
Assess the safety and tolerability of atazanavir when administered BID	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026