Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386503
Status:
COMPLETED
Last Update Posted:
2008-12-09
First Post:
2006-10-10
Brief Title:
Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed Fasted Conditions
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open-Label Cross-Over Study to Compare the Bioavailability of the Fixed Combination of Amodiaquine and Artesunate COARSUCAM After Single Oral Administration Under Fed and Fasted Conditions in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2008-12
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:
Primary Objective to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine AQ and artesunate AS COARSUCAM in healthy male subjects
Secondary Objective to assess the clinical and biological safety and tolerability of Coarsucam
Secondary Objective to assess the clinical and biological safety and tolerability of Coarsucam
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None