Lynn K Pershing1, Judy L Corlett, Joel L Nelson. 1. Department of Dermatology, University of Utah School of Medicine, Salt Lake City 84132, USA. Pershing@ultraderm.med.utah.edu
Abstract
PURPOSE: To compare the dermatopharmacokinetic vs. clinical trial methods for bioequivalence assessment of two miconazole nitrate vaginal cream, 2% products. METHODS: The dermatopharmacokinetic method determined the bioequivalence of two products simultaneously in 24 healthy subjects, as a function of Cmax and AUC(0-1) parameters using miconazole nitrate content in harvested volar forearm stratum corneum. The clinical trial method determined bioequivalence as a function of clinical, mycological culture and therapeutic cure(s) after 7 days of product use and 30 days after therapy cessation in 106 female subjects with positive signs and symptoms of vaginitis, KOH vaginal smears and Candida cultures, randomly assigned to test or reference product. RESULTS: The dermatopharmacokinetic method demonstrated that the two products were not bioequivalent, while the clinical trial method concluded bioequivalence. CONCLUSION: The dermatopharmacokinetic method allowed simultaneous evaluation of both products in the same subject, within the same study period, and was more sensitive and discriminating in the assessment of bioequivalence between the two miconazole nitrate vaginal cream, 2% products than the clinical trial method.
RCT Entities:
PURPOSE: To compare the dermatopharmacokinetic vs. clinical trial methods for bioequivalence assessment of two miconazole nitrate vaginal cream, 2% products. METHODS: The dermatopharmacokinetic method determined the bioequivalence of two products simultaneously in 24 healthy subjects, as a function of Cmax and AUC(0-1) parameters using miconazole nitrate content in harvested volar forearm stratum corneum. The clinical trial method determined bioequivalence as a function of clinical, mycological culture and therapeutic cure(s) after 7 days of product use and 30 days after therapy cessation in 106 female subjects with positive signs and symptoms of vaginitis, KOH vaginal smears and Candida cultures, randomly assigned to test or reference product. RESULTS: The dermatopharmacokinetic method demonstrated that the two products were not bioequivalent, while the clinical trial method concluded bioequivalence. CONCLUSION: The dermatopharmacokinetic method allowed simultaneous evaluation of both products in the same subject, within the same study period, and was more sensitive and discriminating in the assessment of bioequivalence between the two miconazole nitrate vaginal cream, 2% products than the clinical trial method.