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Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

Bacterial Infections Clinical Trial

Official title:
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule 500 Mg Formulations, In Healthy Volunteers Using Formulations (Frademicina®) Manufactured By Pfizer Laboratories Ltd

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01058824
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date April 2009
Completion date April 2009
View Details
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