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An open-label, randomized, cross-over bioequivalence studyof montelukast 10 mg tablets in healthy Thai volunteers |
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| รหัสดีโอไอ | |
| Creator | 1. Chaveewan Ratanajamit 2. Bodin Khwannimit 3. Kiticha Chotephinyononte |
| Title | An open-label, randomized, cross-over bioequivalence studyof montelukast 10 mg tablets in healthy Thai volunteers |
| Publisher | Research and Development Office, Prince of Songkla University |
| Publication Year | 2560 |
| Journal Title | Songklanakarin Journal of Science and Technology (SJST) |
| Journal Vol. | 39 |
| Journal No. | 3 |
| Page no. | 335 |
| Keyword | bioequivalence,montelukast,pharmacokinetics,LC/MS/MS,allergic rhinitis,asthma |
| ISSN | 0125-3395 |
| Abstract | To determine bioequivalence of a generic 10 mg montelukast tablet formulation. A 2-period, 2- sequence crossoverstudy was designed. It included 28 healthy subjects, each subject received a single dose of the randomly assigned formulationwith 240 ml water after 10-hr fasting, and 14 blood samples (6 mL each) were drawn at predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3,3.5, 4, 7, 10, 12 and 24 hr post-dose. The procedure was repeated after a 7-day washout period. Plasma samples were stored at-20?C until analysed using LC-MS/MS, LLOQ 5 ng/mL. The mean ? SD for the test and the reference were: Cmax568?185 and570?205 ng/mL; and AUC0-" 3864?1228 and 4022?1331 ng.hr/mL, respectively. The log-transformed ratios (90% CI) were: Cmax:99.64% (92.80% - 109.66%); and AUC0-?: 99.79 (92.25% - 102.37%). The two formulations were bioequivalent as the 90% CIfor the log-transformed ratios for the mean Cmax, and AUC0-? were within the 80-125%. |
