Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00835705
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2009-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions
Sponsor:
Teva Pharmaceuticals USA
Organization:
Study Overview
Official Title:
Randomized, 2-way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets and AUGMENTIN® 400 Mg-57 mg Chewable Tablets Administered as 1 x 400 Mg-57 mg Chewable Tablet in Healthy Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2024-08
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 objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.
Detailed Description:
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Statistical Methods: FDA bioequivalence statistical methods
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?: