Infections, Respiratory Tract Clinical Trial
Official title:
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations Containing 1 g of Cephalexin (GlaxoSmithKline México, S.A. de C.V. vs. Keflex® 1g, Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers.
The objective of this study was to confirm if two formulations of cephalexin tablets are
bioequivalent.
Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1
g Cephalexin; Eli Lilly). The single dosage was one tablet.
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 26 healthy volunteers, both genders, adults between 18-40
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.
n/a
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