Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02323594
Status:
COMPLETED
Last Update Posted:
2015-02-24
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Bioequivalence Study of the 90-mg Daclatasvir Tablet Relative to the 3 × 30-mg Daclatasvir Phase 3 Tablets, and Relative Bioavailability Studies of Chewable Pediatric Tablets of Daclatasvir and Asunaprevir in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2014-12
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:
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets.
Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: