Publication:
Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis

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Issued Date

1998

Resource Type

Article

File Type

application/pdf

ISSN

1252208

Other identifier(s)

2-s2.0-0032429324

Rights Holder(s)

Scopus

Bibliographic Citation

Journal of the Medical Association of Thailand. Vol 81, No.12 (1998), p.977-985

Suggested Citation

Manorot M., Louthrenoo W., Teekachunhatean S., Rojanasathien N., Tonsuwannont W. Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis. Journal of the Medical Association of Thailand. Vol 81, No.12 (1998), p.977-985. Retrieved from: https://hdl.handle.net/20.500.14740/7184

Title

Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis

Author(s)

Manorot M.
 Louthrenoo W.
 Teekachunhatean S.
 Rojanasathien N.
 Tonsuwannont W.

Abstract

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.

Subject(s)

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

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URI

https://hdl.handle.net/20.500.14740/7184

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Scopus: Year 1983-2021

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