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%-Benzoyl Peroxide 5%) in Subjects With Acne

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)

Timeline

Start

2010-05-06

Primary completion

2010-06-12

Completion

2010-06-12

Publications

• Background Jones TM, Jasper S, Alio Saenz AB. Bioavailability of Clindamycin From a New Clindamycin Phosphate 1.2%-Benzoyl Peroxide 3% Combination Gel. Clin Pharmacol Drug Dev. 2013 Jan;2(1):33-47. doi: 10.1002/cpdd.7. Epub 2013 Mar 4.

Drugs

Indications