Please use this identifier to cite or link to this item: https://ir.swu.ac.th/jspui/handle/123456789/15328
ชื่อเรื่อง: Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis
ผู้แต่ง: Manorot M.
Louthrenoo W.
Teekachunhatean S.
Rojanasathien N.
Tonsuwannont W.
Keywords: methotrexate
adult
article
bioequivalence
clinical article
clinical trial
controlled clinical trial
controlled study
crossover procedure
double blind procedure
drug bioavailability
female
fluorescence polarization immunoassay
human
male
oral drug administration
randomized controlled trial
rheumatoid arthritis
Adult
Antirheumatic Agents
Arthritis, Rheumatoid
Biological Availability
Cross-Over Studies
Double-Blind Method
Female
Humans
Male
Methotrexate
Middle Aged
วันที่เผยแพร่: 1998
บทคัดย่อ: The bioavailability of the two generic methotrexate oral preparations (Emtrexate®, Pharmachemie Company, Hollland and Methotrexate Remedica®, Remedica, Cyprus as the test preparations), were compared to the innovator (Methotrexate Lederle®, Lederle, U.S.A. as the reference) in 10 patients with rheumatoid arthritis. A single 7.5 mg oral dose of each preparation was given to the subjects in a randomized, double-blind, three-period crossover design with a 1 week washout period. Serum methotrexate concentrations were determined by using Fluorescence Polarization Immunoassay (Abbott TDx®). No significant differences in pharmacokinetic parameters (AUC, Cmax, and Tmax) were observed between the test and reference preparations. The mean and 90 per cent CI of the ratio Emtrexate/Methotrexate Lederle® and Methotrexate Remedica®/ Methotrexate Lederle® of the Cmax , AUC0-8, and AUC0-α were 0.93 (0.87-1.00), 0.9 (0.82-0.98), 0.88 (0.79-0.99) and 0.97 (0.93-1.02), 0.95 (0.90-0.99), 0.94 (0.86-1.02), respectively. These values were well within the acceptable bioequivalence range of 0.8-1.25. The mean and 90 per cent CI of Tmax difference between Emtrexate®-Methotrexate Lederle® and Methotrexate Remedica®-Methotrexate Lederle® also overlapped the stipulated bioequivalence range of the Tmax differences of ± 0.25 hour. Thus, Emtrexate® and Methotrexate Remedica® were considered bioequivalent to the reference Methotrexate Lederle® regarding the rate of absorption and the extent of absorption.
URI: https://ir.swu.ac.th/jspui/handle/123456789/15328
https://www.scopus.com/inward/record.uri?eid=2-s2.0-0032429324&partnerID=40&md5=719cf2db66f2da081fa361a84f26faea
ISSN: 1252208
Appears in Collections:Scopus 1983-2021

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