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Bioequivalence Study of an Amoxicillin-Clavulanic

NCT01772238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-08-04

No results posted yet for this study

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

DRUG

400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml

Reference product

DRUG

400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml

Test product

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-22
Primary Completion
2011-03-30
Completion
2011-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772238 on ClinicalTrials.gov