NCT01058824

Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Lincomycin	Single Dose Hard Gelatin Capsule - oral - 500 mg
DRUG	Lincomycin	Single Dose Hard Gelatin Capsule - oral - 500 mg

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2010-01-29
• Last updated: 2011-04-26

Locations

2 sites across 1 country: Brazil