At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
amoxicillin-clavulanic acid +1 moredrug
Likely dose
amoxicillin-clavulanic acid 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Fed Conditions
In Brief
A Phase 1 clinical trial evaluating amoxicillin-clavulanic acid and Augmentin® for Healthy. Completed, enrolled 52 participants across 1 site.
Detailed 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 fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2003
Primary CompletionSep 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 4, 2009
Enrollment StartSep 1, 2003
Primary CompletionSep 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
amoxicillin-clavulanic aciddrug
400 mg-57 mg chewable tablet
Augmentin®drug
400 mg-57 mg chewable tablet