Publication: Bioequivalence study of 50 mg sertraline tablets in healthy Thai volunteers
Issued Date
2009-09-01
Resource Type
ISSN
01252208
01252208
01252208
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2-s2.0-70349267571
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of the Medical Association of Thailand. Vol.92, No.9 (2009), 1229-1233
Suggested Citation
Suvimol Niyomnaitham, Somruedee Chatsiricharoenkul, Korbtham Sathirakul, Piyapat Pongnarin, Supornchai Kongpatanakul Bioequivalence study of 50 mg sertraline tablets in healthy Thai volunteers. Journal of the Medical Association of Thailand. Vol.92, No.9 (2009), 1229-1233. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/27958
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Title
Bioequivalence study of 50 mg sertraline tablets in healthy Thai volunteers
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Abstract
Objective: To determine the bioavailability of 50 mg sertraline tablets between the test product (Zotaline®, M&H Manufacturing Co., Ltd., Thailand) and the reference product (Zoloft®, Pfizer Australia Pty Ltd., Australia). Material and Method: An open-labeled, single dose, 2-treatment, 2-period, 2-sequence, randomized crossover study under fasting conditions with 14 days washout period was conducted in 24 healthy Thai volunteers. Blood samples were collected before dosing and at frequent intervals for up to 96 h post dose. Analysis of sertraline concentrations was performed using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Results: Twenty-four volunteers completed both treatment periods. Pharmacokinetic parameters were determined using the non-compartment model. The 90 percent confidence intervals of the geometric mean ratios (test/reference) of C max 104.47% (96.64%-112.93%), AUC0-96 108.06% (100.71%-115.94%) and AUC0-∞ 108.39% (100.93%-116.40%) fell within the equivalence range (80%-125%). There was no significant difference of the Tmax parameter between the two formulations (p < 0.05). No serious adverse events related to the study drugs were found. Conclusion: The two formulations of sertraline tablets were bio-equivalent in Thai healthy volunteers.