NCT01767532

Bioequivalence Study of Cephalexin Suspension 125

Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparation of Cephalexin 125 mg/ 5 ml (Ceporex® GlaxoSmithKline México, S.A. de C.V. vs. Keflex®, Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 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 28 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	Cephalexin 125 mg/5ml	Reference product 20 ml
DRUG	Cephalexin 125 mg/5ml	Test product 20 ml

Timeline

• Start date: 2011-01-30
• Primary completion: 2011-02-08
• Completion: 2011-02-08
• First posted: 2013-01-14
• Last updated: 2017-06-22