An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers
To determine bioequivalence of a generic 10 mg montelukast tablet formulation. A 2-period, 2- sequence crossover study was designed. It included 28 healthy subjects, each subject received a single dose of the randomly assigned formulation with 240 ml water after 10-hr fasting, and 14 blood samples...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Prince of Songkla University
2017-06-01
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| Series: | Songklanakarin Journal of Science and Technology (SJST) |
| Subjects: | |
| Online Access: | http://rdo.psu.ac.th/sjstweb/journal/39-3/39-3-7.pdf |
| _version_ | 1818513779682443264 |
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| author | Chaveewan Ratanajamit Bodin Khwannimit Kiticha Chotephinyononte |
| author_facet | Chaveewan Ratanajamit Bodin Khwannimit Kiticha Chotephinyononte |
| author_sort | Chaveewan Ratanajamit |
| collection | DOAJ |
| description | To determine bioequivalence of a generic 10 mg montelukast tablet formulation. A 2-period, 2- sequence crossover
study was designed. It included 28 healthy subjects, each subject received a single dose of the randomly assigned formulation
with 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: Cmax
568±185 and
570±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% CI
for the log-transformed ratios for the mean Cmax
, and AUC0-
were within the 80-125%. |
| first_indexed | 2024-12-11T00:06:16Z |
| format | Article |
| id | doaj.art-9de300e4e7794d748ee01b6bda53515d |
| institution | Directory Open Access Journal |
| issn | 0125-3395 |
| language | English |
| last_indexed | 2024-12-11T00:06:16Z |
| publishDate | 2017-06-01 |
| publisher | Prince of Songkla University |
| record_format | Article |
| series | Songklanakarin Journal of Science and Technology (SJST) |
| spelling | doaj.art-9de300e4e7794d748ee01b6bda53515d2022-12-22T01:28:19ZengPrince of Songkla UniversitySongklanakarin Journal of Science and Technology (SJST)0125-33952017-06-0139333534010.14456/sjst-psu.2017.36An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteersChaveewan Ratanajamit0Bodin Khwannimit1Kiticha Chotephinyononte2Clinical and Pharmacological Research Unit, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Songkhla, 90110 ThailandDepartment of Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110 ThailandAll Research Co., Ltd., 23, Sukhumvit Road 62, Bangchark, Phra Khanong, Bangkok, 10260 ThailandTo determine bioequivalence of a generic 10 mg montelukast tablet formulation. A 2-period, 2- sequence crossover study was designed. It included 28 healthy subjects, each subject received a single dose of the randomly assigned formulation with 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: Cmax 568±185 and 570±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% CI for the log-transformed ratios for the mean Cmax , and AUC0- were within the 80-125%.http://rdo.psu.ac.th/sjstweb/journal/39-3/39-3-7.pdfbioequivalencemontelukastpharmacokineticsLC/MS/MSallergic rhinitisasthma |
| spellingShingle | Chaveewan Ratanajamit Bodin Khwannimit Kiticha Chotephinyononte An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers Songklanakarin Journal of Science and Technology (SJST) bioequivalence montelukast pharmacokinetics LC/MS/MS allergic rhinitis asthma |
| title | An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers |
| title_full | An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers |
| title_fullStr | An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers |
| title_full_unstemmed | An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers |
| title_short | An open-label, randomized, cross-over bioequivalence study of montelukast 10 mg tablets in healthy Thai volunteers |
| title_sort | open label randomized cross over bioequivalence study of montelukast 10 mg tablets in healthy thai volunteers |
| topic | bioequivalence montelukast pharmacokinetics LC/MS/MS allergic rhinitis asthma |
| url | http://rdo.psu.ac.th/sjstweb/journal/39-3/39-3-7.pdf |
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