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Comparative pharmacokinetic analysis of a novel sustained-release dosage form of diclofenac sodium in healthy subjects.
Int J Clin Pharmacol Ther Toxicol. 1988 May; 26(5):246-8.IJ

Abstract

The pharmacokinetics and relative bioavailability of diclofenac sodium from a new sustained-release formulation (Effekton-100) and from a standard sustained-release formulation (Voltaren-Retard) were compared in 11 healthy adult male volunteers. After a single oral dose of 100 mg Effekton-100, a mean maximal plasma concentration (Cmax) of 497 +/- 120 ng/ml was obtained after 7.4 h (tmax). After an identical dose of Voltaren-Retard, a peak plasma concentration of 654 +/- 329 ng/ml was obtained after 6.4 h. Plasma levels of diclofenac were determined by a new HPLC assay which was developed as part of this study and makes possible monitoring plasma levels of diclofenac for 24 h after a single dose. The mean bioavailability of diclofenac from Effekton-100 was 0.97 +/- 0.28 relative to that of Voltaren-Retard. As the rate and the extent of absorption of diclofenac sodium was not significantly different after the administration of the two investigated formulations, it can be concluded that Effekton-100 is bioequivalent to Voltaren-Retard.

Authors+Show Affiliations

Department of Internal Medicine B, Hadassah Medical Center, Jerusalem, Israel.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

3410601

Citation

Raz, I, et al. "Comparative Pharmacokinetic Analysis of a Novel Sustained-release Dosage Form of Diclofenac Sodium in Healthy Subjects." International Journal of Clinical Pharmacology, Therapy, and Toxicology, vol. 26, no. 5, 1988, pp. 246-8.
Raz I, Hussein Z, Samara E, et al. Comparative pharmacokinetic analysis of a novel sustained-release dosage form of diclofenac sodium in healthy subjects. Int J Clin Pharmacol Ther Toxicol. 1988;26(5):246-8.
Raz, I., Hussein, Z., Samara, E., & Ben-David, J. (1988). Comparative pharmacokinetic analysis of a novel sustained-release dosage form of diclofenac sodium in healthy subjects. International Journal of Clinical Pharmacology, Therapy, and Toxicology, 26(5), 246-8.
Raz I, et al. Comparative Pharmacokinetic Analysis of a Novel Sustained-release Dosage Form of Diclofenac Sodium in Healthy Subjects. Int J Clin Pharmacol Ther Toxicol. 1988;26(5):246-8. PubMed PMID: 3410601.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative pharmacokinetic analysis of a novel sustained-release dosage form of diclofenac sodium in healthy subjects. AU - Raz,I, AU - Hussein,Z, AU - Samara,E, AU - Ben-David,J, PY - 1988/5/1/pubmed PY - 1988/5/1/medline PY - 1988/5/1/entrez SP - 246 EP - 8 JF - International journal of clinical pharmacology, therapy, and toxicology JO - Int J Clin Pharmacol Ther Toxicol VL - 26 IS - 5 N2 - The pharmacokinetics and relative bioavailability of diclofenac sodium from a new sustained-release formulation (Effekton-100) and from a standard sustained-release formulation (Voltaren-Retard) were compared in 11 healthy adult male volunteers. After a single oral dose of 100 mg Effekton-100, a mean maximal plasma concentration (Cmax) of 497 +/- 120 ng/ml was obtained after 7.4 h (tmax). After an identical dose of Voltaren-Retard, a peak plasma concentration of 654 +/- 329 ng/ml was obtained after 6.4 h. Plasma levels of diclofenac were determined by a new HPLC assay which was developed as part of this study and makes possible monitoring plasma levels of diclofenac for 24 h after a single dose. The mean bioavailability of diclofenac from Effekton-100 was 0.97 +/- 0.28 relative to that of Voltaren-Retard. As the rate and the extent of absorption of diclofenac sodium was not significantly different after the administration of the two investigated formulations, it can be concluded that Effekton-100 is bioequivalent to Voltaren-Retard. SN - 0174-4879 UR - https://www.unboundmedicine.com/medline/citation/3410601/Comparative_pharmacokinetic_analysis_of_a_novel_sustained_release_dosage_form_of_diclofenac_sodium_in_healthy_subjects_ L2 - https://antibodies.cancer.gov/detail/CPTC-HLA-B-1 DB - PRIME DP - Unbound Medicine ER -