Bioequivalence study of 50 mg sertraline tablets in healthy Thai volunteers.
J Med Assoc Thai
; 92(9): 1229-33, 2009 Sep.
Article
em En
| MEDLINE
| ID: mdl-19772184
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 ANDMETHOD:
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.CONCLUSION:
The two formulations of sertraline tablets were bio-equivalent in Thai healthy volunteers.
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Base de dados:
MEDLINE
Assunto principal:
Medicamentos Genéricos
/
Inibidores Seletivos de Recaptação de Serotonina
/
Sertralina
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article