Bioequivalence study of postcoital emergency contraceptions containing levonorgestrel.
OBJECTIVE
The progestogen-only method of emergency contraception, levonorgestrel, is one of the effectiveness in preventing expected pregnancies. The comparative bioavailability was carried out on levonorgestrel tablets (0.75 mg) from two different sources (Hungarian and Thai made).


METHODS
Eighteen healthy female volunteers were given a single oral dose of 0.75 mg tablets in a crossover design. Serum levonorgestrel concentration was determined by radio-immunoassay. The pharmacokinetic analysis of serum levonorgestrel concentration from each treatment was established. The comparative bioavailability of the two products was determined by the analysis of variance (ANOVA) for two way crossover design.


RESULTS
The results found that the mean peak (X +/- SD) serum concentration (Cmax) of the Thai-made pill and Hungarian-pill were 1.18 +/- 0.12 and 1.14 +/- 0.10 ng/ml, respectively. The 90% confidence intervalfor the difference of log Cmax mean was 99.54-120.78%. The time to peak serum concentration (Tmax) of the Thai-made pill and Hungarian-pill were 1.56 +/- 0.73 and 1.58 +/- 0.67 hrs, respectively. The different time of peak serum levonorgestrel concentration was 1.27%. The mean area under the curve (AUC) of Thai-made pill and Hungarian-pill were 2.14 +/- 0.21 and 2.09 +/- 0.16 ng.h/ml, respectively. The 90% confidence interval for the difference of log AUC mean was 103.27 - 121.89%.


CONCLUSIONS
The present study revealed that the 90% confidence interval for the difference of log Cmax mean and log AUC mean were in the criteria of acceptance, which should be within 80-125%. So, the authors can conclude that the Thai-made pill was bioequivalent to the Hungarian-pill.
Chompootaweep
Sumana
S
Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.
Leepipatpibul
Samai
S
D000328:Adult; D003283:Contraceptives, Postcoital, Synthetic; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000493:pharmacokinetics*; D009644:Norgestrel / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D003283:Contraceptives, Postcoital, Synthetic; D009644:Norgestrel; D016912:Levonorgestrel