Bioequivalence of progesterone sustained release suppository in rabbits
| Autor: | Wu Minghui, Dai Zong-shun, Long Lihong, Huang Qun, Hou Shuxian |
|---|---|
| Rok vydání: | 2005 |
| Předmět: |
medicine.medical_specialty
Biomedical Engineering Cmax Biological Availability Pharmacology Bioequivalence Suppository Multiple dosing Multiple dose Biochemistry Biomaterials Random Allocation Pharmacokinetics Administration Rectal Internal medicine Genetics medicine Animals Progesterone Earth-Surface Processes Cross-Over Studies business.industry Suppositories Crossover study Bioavailability Endocrinology Female Rabbits business |
| Zdroj: | Journal of Huazhong University of Science and Technology [Medical Sciences]. 25:470-472 |
| ISSN: | 1993-1352 1672-0733 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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