Bioequivalence evaluation of two sertraline tablet formulations in healthy male volunteers after a single dose administration
Zhu, C.J.; Wu, J.F.; Qu, Z.W.; Chen, L.M.; Zhang, J.T.
International Journal of Clinical Pharmacology and Therapeutics 37(3): 120-124
1999
ISSN/ISBN: 0946-1965 PMID: 10190759 Document Number: 1410
Subjects, material and methods: According to a randomized two-period cross-over design, 12 Chinese male volunteers were treated with 2 sertraline tablet formulations, one was made in China as test tablet, the other was made in England as reference tablet. Each volunteer received each sertraline in a single dose of 150 mg. The 2 medications were carried out by a wash-out phase of 23 days. Blood samples were obtained just before dosing and at 10 time points until 96 hours after administration, and plasma sertraline concentrations were determined by a sensitive gas-chromagraphy electron-capture method with a lower limit of quantification of 0.625 ng/ml. The bioequivalence of 2 formulations was evaluated by the shortest 90% confidence interval method which corresponds to the two one-sided test method. Results: The point estimate (90% confidence interval) of the mean ratio (test/reference) for AUC0-96 was 97.19% (82.66% to 122.33%), for Cmax 96.27% (83.64% to 121.36%), and for t1/2 96.31% (85.43% to 119.57%). Regarding Tmax (test-reference), the 90% confidence interval ranged from -4 to +4 hours, but the difference between the Tmax values of 2 products is clinically of minor importance. Conclusion: Therefore, it can be concluded that 2 sertraline tablet formulations are bioequivalent.
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