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Comparative bioavailability study of a generic sustained release diclofenac sodium tablet.
Med J Malaysia. 2004 Aug; 59(3):352-6.MJ

Abstract

The bioavailability of a generic diclofenac sodium sustained release tablet preparation (Zolterol, SR) was compared with the innovator product, Voltaren, SR. Twelve healthy adult male volunteers participated in the study, which was conducted according to a randomized, two-way crossover design with a wash out period of one week. The bioavailability of diclofenac was compared using the parameters area under the plasma concentration-time curve (AUC(0-infinity)), peak plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax). No statistically significant difference was observed for both logarithmically transformed AUC(0-infinity), Cmax values and Tmax value of the two preparations.

Authors+Show Affiliations

School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15727381

Citation

Magosso, E, et al. "Comparative Bioavailability Study of a Generic Sustained Release Diclofenac Sodium Tablet." The Medical Journal of Malaysia, vol. 59, no. 3, 2004, pp. 352-6.
Magosso E, Yuen KH, Choy WP, et al. Comparative bioavailability study of a generic sustained release diclofenac sodium tablet. Med J Malaysia. 2004;59(3):352-6.
Magosso, E., Yuen, K. H., Choy, W. P., Ling, S. S., Ng, B. H., Ur-Rahman, N., & Wong, J. W. (2004). Comparative bioavailability study of a generic sustained release diclofenac sodium tablet. The Medical Journal of Malaysia, 59(3), 352-6.
Magosso E, et al. Comparative Bioavailability Study of a Generic Sustained Release Diclofenac Sodium Tablet. Med J Malaysia. 2004;59(3):352-6. PubMed PMID: 15727381.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative bioavailability study of a generic sustained release diclofenac sodium tablet. AU - Magosso,E, AU - Yuen,K H, AU - Choy,W P, AU - Ling,S S N, AU - Ng,B H, AU - Ur-Rahman,N, AU - Wong,J W, PY - 2005/2/25/pubmed PY - 2005/5/20/medline PY - 2005/2/25/entrez SP - 352 EP - 6 JF - The Medical journal of Malaysia JO - Med J Malaysia VL - 59 IS - 3 N2 - The bioavailability of a generic diclofenac sodium sustained release tablet preparation (Zolterol, SR) was compared with the innovator product, Voltaren, SR. Twelve healthy adult male volunteers participated in the study, which was conducted according to a randomized, two-way crossover design with a wash out period of one week. The bioavailability of diclofenac was compared using the parameters area under the plasma concentration-time curve (AUC(0-infinity)), peak plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax). No statistically significant difference was observed for both logarithmically transformed AUC(0-infinity), Cmax values and Tmax value of the two preparations. SN - 0300-5283 UR - https://www.unboundmedicine.com/medline/citation/15727381/Comparative_bioavailability_study_of_a_generic_sustained_release_diclofenac_sodium_tablet_ L2 - http://www.e-mjm.org/2004/v59n3/Diclofenac_Sodium_Tablet.pdf DB - PRIME DP - Unbound Medicine ER -