drugset / Trial / NCT01058824
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lincomycin | Small molecule | 500 mg | Oral |