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

The bioavailability of the two generic methotrexate oral preparations (Emtrexate, Pharmachemie Company, Holland 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 rheumatoi...

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Main Authors: Manorot M., Rojanasathien N., Louthrenoo W., Tonsuwannont W., Teekachunhatean S.
Format: Clinical Trial
Language:English
Published: 2014
Online Access:http://www.ncbi.nlm.nih.gov/pubmed/3502482
http://cmuir.cmu.ac.th/handle/6653943832/3386
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Institution: Chiang Mai University
Language: English
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spelling th-cmuir.6653943832-33862014-08-30T02:26:04Z Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis Manorot M. Rojanasathien N. Louthrenoo W. Tonsuwannont W. Teekachunhatean S. The bioavailability of the two generic methotrexate oral preparations (Emtrexate, Pharmachemie Company, Holland 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-alpha 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. 2014-08-30T02:26:04Z 2014-08-30T02:26:04Z 1998 Clinical Trial 0125-2208 9916387 http://www.ncbi.nlm.nih.gov/pubmed/3502482 http://cmuir.cmu.ac.th/handle/6653943832/3386 eng
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
language English
description The bioavailability of the two generic methotrexate oral preparations (Emtrexate, Pharmachemie Company, Holland 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-alpha 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.
format Clinical Trial
author Manorot M.
Rojanasathien N.
Louthrenoo W.
Tonsuwannont W.
Teekachunhatean S.
spellingShingle Manorot M.
Rojanasathien N.
Louthrenoo W.
Tonsuwannont W.
Teekachunhatean S.
Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis
author_facet Manorot M.
Rojanasathien N.
Louthrenoo W.
Tonsuwannont W.
Teekachunhatean S.
author_sort Manorot M.
title Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis
title_short Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis
title_full Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis
title_fullStr Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis
title_full_unstemmed Comparative studies of quality and bioavailability of methotrexate in Thai patients with rheumatoid arthritis
title_sort comparative studies of quality and bioavailability of methotrexate in thai patients with rheumatoid arthritis
publishDate 2014
url http://www.ncbi.nlm.nih.gov/pubmed/3502482
http://cmuir.cmu.ac.th/handle/6653943832/3386
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