Bioequivalence of progesterone sustained release suppository in rabbits.
- Author:
Lihong, LONG
;
Qun, HUANG
;
Minghui, WU
;
Shuxian, HOU
;
Zongshun, DAI
- Publication Type:Journal Article
- MeSH:
Administration, Rectal;
Biological Availability;
Cross-Over Studies;
Progesterone/administration & dosage;
Progesterone/*pharmacokinetics;
Random Allocation;
Suppositories
- From:
Journal of Huazhong University of Science and Technology (Medical Sciences)
2005;25(4):470-2
- CountryChina
- Language:English
-
Abstract:
To study the bioequivalence of a kind of progesterone sustained release suppository, a randomized cross-over study was conducted in 12 rabbits. A single rectal dose of 2.75 mg/kg progesterone sustained released suppository (tested formulation, T) and progesterone suppository (reference formulation, R) was administered; a multiple dose of 2.75 mg/kg was given up to seven times with an interval of 8 h. Concentrations in serum were determined by a competitive enzyme immunoassay. The main parameters of T were: for single and multiple doses, Cmax was 48.8 +/- 11.8 ng/mL and 43.5 +/- 9.4 ng/mL, Tmax was 0.5 +/- 0.3 h and 0.4 +/- 0.3 h, AUC(0-24 h) was 362.4 +/- 143 ng x h x mL(-1) and 310.6 +/- 70.3 ng x h x mL(-1), respectively. The relative bioavailability of T to R were (104.2 +/- 13.4)% and (111.4 +/- 19.1)%, respectively. Statistical analysis showed that the two formulations were bioequivalent and T had sustained released feature.
