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Comparative bioavailability of two different diclofenac formulations in healthy volunteers.
Arzneimittelforschung. 1999 Nov; 49(11):920-4.A

Abstract

The aim of the study was to assess the bioequivalence of two different diclofenac (CAS 15307-86-5) formulations (diclofenac free acid suspension as test formulation and diclofenac resinate suspension, Cataflam, as reference formulation) in 24 healthy volunteers. After an overnight fast, the volunteers received a single oral dose (50 mg) of each formulation, following an open, randomized, two-period crossover design, with a fourteen-day washout interval between doses. Serum samples were obtained over a 24-h interval post-dosing, and were analysed for their diclofenac content by HPLC-UV. No adverse effect was reported for any of the formulations administered. Geometric mean test/reference individual ratios were: 92.8% for AUC(0-24 h), 93.2% for AUC(0-infinity), 117.2% for Cmax, 131.0% for Ke and 76.2% for T1/2. The variability of Cmax parameter expressed as CV was greater than 25%. Since the 90% CI for AUC(0-24 h) mean ratio were within the 80-125% interval proposed by the Food and Drug Administration, it can be concluded that diclofenac free acid formulation is bioequivalent to diclofenac resinate formulation for the extent of absorption. Since the European Community Agency accepts a 90% CI for Cmax of 70-143%, it can be concluded that diclofenac free acid formulation is bioequivalent to diclofenac resinate formulation for both the rate and the extent of absorption after single dose administration.

Authors+Show Affiliations

Department of Pharmacology, Campinas University, São Paulo, Brazil.No 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10604045

Citation

Silva, L C., et al. "Comparative Bioavailability of Two Different Diclofenac Formulations in Healthy Volunteers." Arzneimittel-Forschung, vol. 49, no. 11, 1999, pp. 920-4.
Silva LC, Simões IG, Lerner FE, et al. Comparative bioavailability of two different diclofenac formulations in healthy volunteers. Arzneimittelforschung. 1999;49(11):920-4.
Silva, L. C., Simões, I. G., Lerner, F. E., Belém, G. R., de Moraes, M. E., & De Nucci, G. (1999). Comparative bioavailability of two different diclofenac formulations in healthy volunteers. Arzneimittel-Forschung, 49(11), 920-4.
Silva LC, et al. Comparative Bioavailability of Two Different Diclofenac Formulations in Healthy Volunteers. Arzneimittelforschung. 1999;49(11):920-4. PubMed PMID: 10604045.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative bioavailability of two different diclofenac formulations in healthy volunteers. AU - Silva,L C, AU - Simões,I G, AU - Lerner,F E, AU - Belém,G R, AU - de Moraes,M E, AU - De Nucci,G, PY - 1999/12/22/pubmed PY - 1999/12/22/medline PY - 1999/12/22/entrez SP - 920 EP - 4 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 49 IS - 11 N2 - The aim of the study was to assess the bioequivalence of two different diclofenac (CAS 15307-86-5) formulations (diclofenac free acid suspension as test formulation and diclofenac resinate suspension, Cataflam, as reference formulation) in 24 healthy volunteers. After an overnight fast, the volunteers received a single oral dose (50 mg) of each formulation, following an open, randomized, two-period crossover design, with a fourteen-day washout interval between doses. Serum samples were obtained over a 24-h interval post-dosing, and were analysed for their diclofenac content by HPLC-UV. No adverse effect was reported for any of the formulations administered. Geometric mean test/reference individual ratios were: 92.8% for AUC(0-24 h), 93.2% for AUC(0-infinity), 117.2% for Cmax, 131.0% for Ke and 76.2% for T1/2. The variability of Cmax parameter expressed as CV was greater than 25%. Since the 90% CI for AUC(0-24 h) mean ratio were within the 80-125% interval proposed by the Food and Drug Administration, it can be concluded that diclofenac free acid formulation is bioequivalent to diclofenac resinate formulation for the extent of absorption. Since the European Community Agency accepts a 90% CI for Cmax of 70-143%, it can be concluded that diclofenac free acid formulation is bioequivalent to diclofenac resinate formulation for both the rate and the extent of absorption after single dose administration. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/10604045/Comparative_bioavailability_of_two_different_diclofenac_formulations_in_healthy_volunteers_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0031-1300527 DB - PRIME DP - Unbound Medicine ER -