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Comparative bioavailability of two suspension formulations of potassium diclofenac in healthy male volunteers.
Int J Clin Pharmacol Ther. 1994 Mar; 32(3):131-5.IJ

Abstract

The bioavailability of two suspension formulations of potassium diclofenac (Flogan, Merck and Cataflam, Ciba-Geigy) were compared in eighteen healthy male volunteers who received a single dose of 7 ml of each suspension (equivalent to 105 mg of potassium diclofenac) in an open randomized two period crossover design, with a fourteen-day washout period between doses. Serum samples were obtained over a 24 hour interval and diclofenac concentrations were determined by HPLC with ultraviolet detection. From the serum diclofenac concentration vs time curves, AUC[0-24] (area under the concentration vs time curves from 0-24 h), Cmax (maximum achieved concentration), Tmax (time to achieve Cmax) and Ke (terminal first order elimination constant) were obtained. Overlapping of Tmax intervals for both formulations was observed, but the important inter-subject variation observed in Cmax ratios did not allow equivalence conclusion for the rate of absorption. Equivalence in the extent of bioavailability between both potassium diclofenac suspension brands was concluded from the analysis of AUC[0-24] ratios.

Authors+Show Affiliations

Miguel Servet Clinical Pharmacology Unit, Department of Pharmacology, Faculty of Medical Sciences, UNICAMP, Campinas, 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

Language

eng

PubMed ID

8205374

Citation

Mendes, G B., et al. "Comparative Bioavailability of Two Suspension Formulations of Potassium Diclofenac in Healthy Male Volunteers." International Journal of Clinical Pharmacology and Therapeutics, vol. 32, no. 3, 1994, pp. 131-5.
Mendes GB, Franco LM, Moreno RA, et al. Comparative bioavailability of two suspension formulations of potassium diclofenac in healthy male volunteers. Int J Clin Pharmacol Ther. 1994;32(3):131-5.
Mendes, G. B., Franco, L. M., Moreno, R. A., Fernandes, A. G., Muscara, M. N., & de Nucci, G. (1994). Comparative bioavailability of two suspension formulations of potassium diclofenac in healthy male volunteers. International Journal of Clinical Pharmacology and Therapeutics, 32(3), 131-5.
Mendes GB, et al. Comparative Bioavailability of Two Suspension Formulations of Potassium Diclofenac in Healthy Male Volunteers. Int J Clin Pharmacol Ther. 1994;32(3):131-5. PubMed PMID: 8205374.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative bioavailability of two suspension formulations of potassium diclofenac in healthy male volunteers. AU - Mendes,G B, AU - Franco,L M, AU - Moreno,R A, AU - Fernandes,A G, AU - Muscara,M N, AU - de Nucci,G, PY - 1994/3/1/pubmed PY - 1994/3/1/medline PY - 1994/3/1/entrez SP - 131 EP - 5 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 32 IS - 3 N2 - The bioavailability of two suspension formulations of potassium diclofenac (Flogan, Merck and Cataflam, Ciba-Geigy) were compared in eighteen healthy male volunteers who received a single dose of 7 ml of each suspension (equivalent to 105 mg of potassium diclofenac) in an open randomized two period crossover design, with a fourteen-day washout period between doses. Serum samples were obtained over a 24 hour interval and diclofenac concentrations were determined by HPLC with ultraviolet detection. From the serum diclofenac concentration vs time curves, AUC[0-24] (area under the concentration vs time curves from 0-24 h), Cmax (maximum achieved concentration), Tmax (time to achieve Cmax) and Ke (terminal first order elimination constant) were obtained. Overlapping of Tmax intervals for both formulations was observed, but the important inter-subject variation observed in Cmax ratios did not allow equivalence conclusion for the rate of absorption. Equivalence in the extent of bioavailability between both potassium diclofenac suspension brands was concluded from the analysis of AUC[0-24] ratios. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/8205374/Comparative_bioavailability_of_two_suspension_formulations_of_potassium_diclofenac_in_healthy_male_volunteers_ L2 - https://www.lens.org/lens/search/patent/list?q=citation_id:8205374 DB - PRIME DP - Unbound Medicine ER -