Bioequivalence Study of 50 mg Sertraline Tablets in Healthy Thai Volunteers
Suvimol Niyomnaitham MD*, Somruedee Chatsiricharoenkul MD*, Korbtham Sathirakul PhD**, Piyapat Pongnarin MSc*, Supornchai Kongpatanakul MD*
Affiliation : * Department of Pharmacology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand ** Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
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 Cmax 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.
Keywords : Bioequivalence, Sertraline, Therapeutic equivalency
