At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL +1 moredrug
Likely dose
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mLfrom 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.
An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL and Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension for Healthy. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2002
Primary CompletionAug 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 10, 2009
Enrollment StartAug 1, 2002
Primary CompletionAug 1, 2002
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mLdrug
1 x 600 mg/42.9 mg/5 mL, single-dose fed
Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspensiondrug
1 x 600 mg/42.9 mg/5 mL, single-dose fed