Bioequivalence of compound levonorgestrel tablets in healthy volunteers

Objective:To study the bioequivalence of two compound levonorgestrel tablets in healthy volunteers.Methods:A single dose of compound levonorgestrel test and reference tablets were orally administered to nineteen male healthy volunteers in a randomized crossover study.Concentrations of levonorgestrel and ethinyloestradiol were determined by radioimmunoassay.The pharmacokinetic parameters of levonorgestrel and ethinyloestradiol were calculated and bioequivalence of the two preparations were evaluated.Results:There were no significant differences in pharmacokinetic parameters of the two preparations(P0.05),except t1/2 of levonorgestrel.Relative bioavailability of levonorgestrel in the test preparation was(101.59±20.30)% and that of ethinyloestradiol was(113.57±26.70)%.Conclusion:The two preparations of compound levonorgestrel tablets are bioequivalent.