NCT00778414

Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg - 42.9 mg/ 5 mL Oral Suspension Under Fasting Conditions

Randomized, Open - Label, 2 - Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 600mg - 42.9 mg/ 5 mL Oral Suspension and Augmentin ES - 600 (Reference) Following a 600 mg - 42.9 mg Dose in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the rate and extent of absorption Ranbaxy Laboratories Limited, India, amoxicillin - clavulanic acid and GlaxoSmithKline, U.S.A. (Augmentin ES-600), amoxicillin - clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9 mg) oral suspension, under fasting conditions.

Detailed description

This was a single center, randomized, single-dose, open-label, 2 - way crossover bioequivalence study to compare the rate and extent of absorption of a test amoxicillin - clavulanic acid versus Augmentin ES - 600, a reference amoxicillin - clavulanic acid, under fasting condition. Prior to study commencement, subjects were randomly assigned to a treatment in accordance with the randomization scheme generated by Anapharm. Subjects were confined to the Anapharm Clinical Research Facility from at least 10 hours prior to the drug administration until after the 12 - hour post dose blood draw, in each period. The treatment phases were separated by a washout period of 20 days. A total of 55 healthy, adult subjects signed the study - specific Informed Consent Form and were confined for Period I; of these subjects, 48 (24 males and 24 females) were enrolled and were dosed in the study; 42 of these enrolled subjects completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amoxicillin-Clavulanic acid 600mg - 42.9 mg/ 5 mL oral suspension

Timeline

• Start date: 2006-06-01
• Primary completion: 2006-07-01
• Completion: 2006-09-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: Canada