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Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants | Clinical Trials | Clareo Health

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Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

Study to Assess the Pharmacokinetic Drug - Drug Interactions Between Atazanavir Plus Ritonavir Coadministered With Voriconazole in Healthy Subjects

NCT00833482•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy participants as determined by no clinically significant deviation from normal
•Body Mass Index (BMI) of 18 to 32 kg/m\^2, inclusive. BMI=weight(kg)/height (m)\^2
•Women who are not of childbearing potential (WOCBP)(ie, who are postmenopausal or surgically sterile) and men, ages 18 to 45 years, inclusive

Exclusion Criteria

•WOCBP
•Sexually active fertile men not using effective birth control if their partners are WOCBP
•Proven or suspected acute hepatitis (within 12 months prior to the 1st dose)
•Any significant acute or chronic medical illness
•Any gastrointestinal surgery that could impact on the absorption of study drug
•Smoking more than 5 cigarettes per day
•History of any hemolytic disorders (including drug-induced hemolysis)
•History of acute or chronic pancreatitis
•History of hypochlorhydria or achlorhydria
•Men and women weighing \<40 kg
+2 more criteria

Locations (2)

West Coast Clinical Trials, Llc

Cypress, California, United States

Local Institution

Nijmegen, Netherlands

Key Dates

Start Date

September 1, 2009

Primary Completion Date

July 1, 2010

Completion Date

February 1, 2011

Last Updated

October 25, 2012

Enrollment

185

ACTUAL participants

Conditions

Human Immunodeficiency Virus Type 1 (HIV-1)HIV Infections

Interventions

Voriconazole

DRUG

Atazanavir

DRUG

Ritonavir

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

Inclusion Criteria

Exclusion Criteria

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