Bioequivalence study of 50 mg sertraline tablets in healthy Thai volunteers.
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).


METHODS
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%), AUC(0-96) 108.06% (100.71%-115.94%) and AUC(0-infinity) 108.39% (100.93%-116.40%) fell within the equivalence range (80%-125%). There was no significant difference of the T(max) parameter between the two formulations (p > 0.05). No serious adverse events related to the study drugs were found.


CONCLUSIONS
The two formulations of sertraline tablets were bio-equivalent in Thai healthy volunteers.
Niyomnaitham
Suvimol
S
Department of Pharmacology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. sisnf@mahidol.ac.th
Chatsiricharoenkul
Somruedee
S
Sathirakul
Korbtham
K
Pongnarin
Piyapat
P
Kongpatanakul
Supornchai
S
D000293:Adolescent; D019540:Area Under Curve; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D017367:Selective Serotonin Reuptake Inhibitors / Q000493:pharmacokinetics*; D020280:Sertraline / Q000493:pharmacokinetics*; D013785:Thailand; D013810:Therapeutic Equivalency; D055815:Young Adult
D016568:Drugs, Generic; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline