TY - JOUR
T1 - Comparative bioavailability of two oral formulations of danazol in Mexican subjects
AU - Aguilar-Carrasco, José C.
AU - Carrasco-Portugal, Norma A.
AU - Carrasco-Portugal, Miriam C.
AU - Herrera, Jorge E.
AU - Flores-Murrieta, Francisco J.
PY - 2006
Y1 - 2006
N2 - Danazol is a synthetic attenuated androgen drug used for the treatment of endometriosis. Currently, there are several sources in Mexico containing this drug; however, very limited information about bioavailability is available. The purpose of this study was to compare the bioavailability of two formulations of danazol used in Mexico, Ladogal® and Danalem®. Twenty-seven healthy volunteers participated in this study that was carried out following the recommendations of the Declaration of Helsinki. Subjects received a dose of 400 mg of danazol under fasting conditions in two separate sessions under a randomized crossover design with a two weeks washout period. Plasma samples were obtained at selected times during a period of 24 hr and stored frozen until analyzed by HPLC. Pharmacokinetic parameters were obtained and values (mean ± s.e.m.) were as follows: Cmax 36.84 ± 3.41 and 37.83 ± 3.65 ng/ml; tmax 2.52 ± 0.34 and 2.20 ± 0.21 h; AUC24h 430.97 ± 53.48 and 423.11 ± 60.62 ng-hr/ml, for Ladogal® tablets and Danalem® tablets, respectively. Pharmacokinetic parameters were compared by analysis of variance and ratios of AUC, Cmax and 90% confidence intervals obtained. Since confidence intervals did not exceed the 70-142.9% limits for Cmax and 80-125% for AUC24hr, we conclude that the formulations tested are bioequivalent.
AB - Danazol is a synthetic attenuated androgen drug used for the treatment of endometriosis. Currently, there are several sources in Mexico containing this drug; however, very limited information about bioavailability is available. The purpose of this study was to compare the bioavailability of two formulations of danazol used in Mexico, Ladogal® and Danalem®. Twenty-seven healthy volunteers participated in this study that was carried out following the recommendations of the Declaration of Helsinki. Subjects received a dose of 400 mg of danazol under fasting conditions in two separate sessions under a randomized crossover design with a two weeks washout period. Plasma samples were obtained at selected times during a period of 24 hr and stored frozen until analyzed by HPLC. Pharmacokinetic parameters were obtained and values (mean ± s.e.m.) were as follows: Cmax 36.84 ± 3.41 and 37.83 ± 3.65 ng/ml; tmax 2.52 ± 0.34 and 2.20 ± 0.21 h; AUC24h 430.97 ± 53.48 and 423.11 ± 60.62 ng-hr/ml, for Ladogal® tablets and Danalem® tablets, respectively. Pharmacokinetic parameters were compared by analysis of variance and ratios of AUC, Cmax and 90% confidence intervals obtained. Since confidence intervals did not exceed the 70-142.9% limits for Cmax and 80-125% for AUC24hr, we conclude that the formulations tested are bioequivalent.
UR - http://www.scopus.com/inward/record.url?scp=34247464361&partnerID=8YFLogxK
M3 - Artículo
SN - 0083-8969
VL - 49
SP - 48
EP - 50
JO - Proceedings of the Western Pharmacology Society
JF - Proceedings of the Western Pharmacology Society
ER -