Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K and Nizoral) in a healthy female Mexican population.
A randomized, crossover study was conducted in 24 healthy female volunteers to compare the bioavailability of two brands of ketoconazole (200 mg) tablets; Onofin-K (Farmacéuticos Rayere S.A., Mexico) as the test and Nizoral (Janssen-Cilag, Mexico) as the reference products. The study was performed at the Clinical Pharmacology Research Center of the Hospital General de Mexico in Mexico City. Two tablets (400 mg) were administered as a single dose with 250 ml of water after a 12 h overnight fast on two treatment days separated by a 1 week washout period. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested was analysed for ketoconazole by a modified and validated HPLC method with UV detection in the range 400-14000 ng/ml, using 200 microl of plasma in a full-run time of 2.5 min. The pharmacokinetic parameters AUC(0-t), AUC(0-alpha), Cmax, Tmax and t(1/2) were determined from plasma concentrations of both formulations and the results discussed. AUC(0-t), AUC(0-alpha) and Cmax were tested for bioequivalence after log transformation of data, and no significant differences were found either in 90% classic confidence interval or in the Anderson and Hauck test (p < 0.05). Based on statistical analysis, it is concluded that Onofin-K is bioequivalent to Nizoral.
Marcelín-Jiménez
G
G
Servicio de Investigación de Farmacología Clínica, Hospital General de México, Mexico City, Mexico. gabmarcelin@hotmail.com
Hernández
José
J
Angeles
Alionka P
AP
Contreras
L
L
Hinojosa
M
M
Rivera
L
L
Martínez-Rossier
L
L
Amancio
O
O
Fernández
A
A
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007654:Ketoconazole / Q000097:blood* / Q000493:pharmacokinetics*; D008800:Mexico; D008875:Middle Aged; D013608:Tablets, Enteric-Coated; D013810:Therapeutic Equivalency
D013608:Tablets, Enteric-Coated; D007654:Ketoconazole