drugset / Trial / NCT01058824

Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

NCT01058824

Phase 1 Completed 36 enrolled Pfizer
RandomizedCrossoverOpen-label

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.

Timeline

Start
2009-04
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lincomycin Small molecule 500 mg Oral