Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-25 @ 2:55 PM
Study NCT ID:
NCT04263350
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2020-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: