Comparison of dermatopharmacokinetic vs. clinicial efficacy methods for bioequivalence assessment of miconazole nitrate vaginal cream, 2% in humans.
OBJECTIVE
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.


CONCLUSIONS
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.
Pershing
Lynn K
LK
Department of Dermatology, University of Utah School of Medicine, Salt Lake City 84132, USA. Pershing@ultraderm.med.utah.edu
Corlett
Judy L
JL
Nelson
Joel L
JL
D000328:Adult; D000704:Analysis of Variance; D002176:Candida albicans / Q000187:drug effects; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy* / Q000378:metabolism; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008825:Miconazole / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D008875:Middle Aged; D012869:Skin Absorption / Q000187:drug effects / Q000502:physiology*; D013810:Therapeutic Equivalency; D014622:Vaginal Creams, Foams, and Jellies; D014627:Vaginitis / Q000188:drug therapy* / Q000378:metabolism
D014622:Vaginal Creams, Foams, and Jellies; D008825:Miconazole