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A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions

NCT05236738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-10-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.

Conditions

  • Healthy Participants

Interventions

DRUG

Atazanavir

Specified dose on specified days

DRUG

Cobicistat

Specified dose on specified days

DRUG

Atazanavir/Cobicistat Mini-tablet

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2022-07-05
Completion
2022-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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 NCT05236738 on ClinicalTrials.gov