NCT00836056

Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Clindamycin 300 mg Capsules and Cleocin HCl Administered as 1 x 300 mg Capsule in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Clindamycin 300 mg capsule	1 x 300 mg
DRUG	Cleocin HCl 300 mg capsules	1 x 300 mg

Timeline

• Start date: 2003-11-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2009-02-04
• Last updated: 2024-08-19
• Results posted: 2009-07-21

Locations

1 site across 1 country: Canada