Bioavailability of mifepristone in capsule versus tablet form in healthy nonpregnant women
| Autor: | Xue-bing Pang, Zhongming Xiong, Xirui Wu, Hong-gang Li, Ai-Hua Liao |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Adult
Population Administration Oral Biological Availability Capsules Pharmacology Bioequivalence Dosage form Pharmacokinetics Humans Medicine education Abortifacient education.field_of_study Contraceptives Postcoital Synthetic Cross-Over Studies business.industry Area under the curve Obstetrics and Gynecology Crossover study Bioavailability Mifepristone Reproductive Medicine Female business Chromatography Liquid Tablets |
| Zdroj: | Contraception. 77:431-434 |
| ISSN: | 0010-7824 |
| DOI: | 10.1016/j.contraception.2008.02.009 |
| Popis: | Background The study was conducted to assess the bioavailability of two formulations of mifepristone in capsule and tablet forms at a single dose of 75 mg (half the registered dose in China). Study Design A randomized two-way crossover study was conducted in 18 healthy nonpregnant women. Each subject was orally given a single dose of mifepristone at 75 mg in capsule or tablet form on an alternate basis. Serial blood samples were collected over a period of 96 h and assayed for the plasma concentration of mifepristone by high-performance liquid chromatography. Paired t tests were used to compare the capsule and tablet forms in terms of maximum concentration ( C max ), time to maximum concentration ( T max ) and area under the curve over 96 h (AUC 0–96h ). Relative bioavailability (capsule/tablet) was derived from AUC 0–96h . Bioequivalability was analyzed by two one-sided t tests. Results The major pharmacokinetic parameters were as follows: C max values were 1.26±0.38 and 1.25±0.40 mcg/mL, T max values were 0.94±0.34 and 0.89±0.47 h, T 1/2Ke values were 36.2±21.0 and 33.4±12.3 h and AUC (0–96h) values were 19.7±6.4 and 19.6±9.9 mcg·h/mL for mifepristone in capsule and tablet forms, respectively. No significant difference was observed among these parameters. The relative bioavailability was 109.4±34.8%. Conclusion This study suggests that the two formulations of mifepristone are bioequivalent, which provides pharmacokinetic evidence for further reducing the dosage of mifepristone in clinical use. |
| Databáze: | OpenAIRE |
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