Comparative pharmacokinetic study of a single dose of two prolonged- release formulations of diclofenac in healthy subjects

Current Therapeutic Research - Clinical and Experimental

Volumn 59, Issue 11, 1998, Pages 785-792

  Biasi, Giovanni ^a   Canova, Nadia ^b   Palazzini, Emesto ^b   Marcolongo, Roberto ^a  

^a UNIVERSITY HOSPITAL OF SIENA   (Italy)

^b Alfa Wassermann SpA   (Italy)

Author keywords

Diclofenac sodium; Pharmacokinetics; Prolonged release formulation

Indexed keywords

DICLOFENAC;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE TIME EFFECT RELATION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG HALF LIFE; FEMALE; HUMAN; MALE; MEAN RESIDENCE TIME; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SUSTAINED RELEASE FORMULATION;

EID: 0031755956     PISSN: 0011393X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0011-393X(98)85104-7     Document Type: Article

References (9)

1. Dicloreum. Prescribing Information Package Insert. No. 01151600. Alfa Wassermann SpA, Bologna, Italy. Revised June 1995.
2. John VA. The pharmacokinetics and metabolism of diclofenac sodium (Voltarol) in animals and man. Rheumatol Rehabil. 1979;17(Suppl 2):22-35.
3. Kendall MJ, Thornhill DP, Willis JV. Factors affecting the pharmacokinetics of diclofenac sodium. Rheumatol Rehabil. 1979;17(Suppl 2):38-45.
4. Thakker KM, Mangat S, Wagner W, et al. Effect of food and relative bioavailability following single doses of diclofenac 150 mg hydrogel bead (HGB) capsules in healthy humans. Biopharm Drug Dispos. 1992;13:327-335.
5. Giachetti C, Poletti P, Zanolo G. Determination of diclofenac in plasma samples. Comparison between HRGC and HPLC. J High Resol Chromat and Chromat Com. 1987;10: 469-471.
6. EMEA-CPMP Guideline: Investigation of Bioavailability and Bioequivalence. London: European Agency for the Evaluation of Medicinal Products; (III/54/89) Part 2, Vol. III, January 1996.
7. Todd PA, Sorkin EM. Diclofenac sodium. A reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs. 1988;35:244-285.
8. Hasan MM, Najib NM, Muti H. A comparative bioavailability study on two sustained-release formulations of diclofenac sodium following a single dose administration. Int J Clin Pharmacol Ther Toxicol. 1993;31:387-391.
9. Willis JV, Kendall MJ, Jack DB. The influence of food on the absorption of diclofenac after single and multiple oral doses. Eur J Clin Pharmacol. 1981;19:33-37.