NCT01772238

Bioequivalence Study of an Amoxicillin-Clavulanic

Bioequivalence Study of an Amoxicillin-Clavulanic Acid Suspension Preparation. Cross-over, Randomized, Single Dose, Two Treatments, Two Periods and Two Sequences Trial in Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to confirm if two formulations of amoxicillin and clavulanic acid (suspension) are bioequivalent. Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 35 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Conditions

• Infections, Respiratory Tract

Interventions

Type	Name	Description
DRUG	400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml	Reference product
DRUG	400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml	Test product

Timeline

• Start date: 2011-03-22
• Primary completion: 2011-03-30
• Completion: 2011-03-30
• First posted: 2013-01-21
• Last updated: 2017-08-04