Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522763
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Bioequivalence Study of SulfadoxinePyrimethamine 50025 mg Dispersible Tablet
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Randomized Single Dose Two-Arm Parallel Open Label Study to Determine the Bioequivalence of SulfadoxinePyrimethamine 50025 mg Dispersible Tablet After an Oral Administration to Healthy Adults Under Fasting Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0-72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions The secondary objectives of present study are to describe the Tmax and assess the safety and tolerability profile of both test and reference products
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