Overview

W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzo

Status:
Completed

Trial end date:
2010-06-12

Target enrollment:

Participant gender:

Summary

This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products: - CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free - Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP) - Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)

Phase:

Phase 1

Details

Lead Sponsor:

Stiefel, a GSK Company

Collaborator:

GlaxoSmithKline

Treatments:

Benzoyl Peroxide
Clindamycin
Clindamycin palmitate
Clindamycin phosphate