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Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

2014-07-24 14:10:10 | BioPortfolio

Summary

To assess the relative bioavailability of two different batches of Frademicina® drug product, containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd. The formulations' comparative bioavailability after oral administration will be assessed based on the statistical comparisons of the relevant pharmacokinetic parameters, obtained from the drug concentrations in the blood. The lincomycin hydrocloride concentration will be measured by a proper and validated analytical method.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Bacterial Infections

Intervention

Lincomycin, Lincomycin

Location

Pfizer Investigational Site
Campinas
Sao Paulo
Brazil
13012-000

Status

Completed

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:10-0400

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