Comparative steady state study with 2 Fenofibrate 250 mg slow release capsules. An example of bioequivalence assessment with a highly variable drug

International Journal of Clinical Pharmacology and Therapeutics

Volumn 34, Issue 8, 1996, Pages 345-348

  Doser, K ^a,d   Guserle, R ^a   Nitschie, V ^b   Arnold, G ^c  

^a Pharmakin GmbH   (Germany)

^b Biokinet GmbH   (Austria)

^c MTT Med and Technol Transfer GmbH   (Germany)

^d Pharmakin GmbH   (Germany)

Author keywords

Bioequivalence; Fenofibrate; Human; Nonfasting; Pharmacokinetics; Steady state

Indexed keywords

FENOFIBRATE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CALIBRATION; CALORIC INTAKE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG COMPARISON; DRUG DOSE; DRUG FORMULATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PHARMACEUTICS; PHARMACOKINETICS; RANDOMIZED CONTROLLED TRIAL; STEADY STATE;

ADULT; ANALYSIS OF VARIANCE; ANTILIPEMIC AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DELAYED-ACTION PREPARATIONS; HUMANS; MALE; PROCETOFEN; THERAPEUTIC EQUIVALENCY;

EID: 0029770667     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. Balfour JA, Mc Tavish D, Heel RC 1990 Fenofibrate. A review of its pharmacodynamic properties and therapeutic use in dyslipidaemia. Drugs 40: 260-290
2. Caldwell J 1989 The biochemical pharmacology of fenofibrate. Cardiology 76 (Suppl 1): 33-44
3. CPMP Working Party on the Efficacy of Medicinal Products 1991 Note for guidance: Investigation of bioavailability and bioequivalence. III/54/89-EN
4. Desager JP, Harvengt C 1978 Clinical pharmacokinetic study of procetofene, a new hypolipidemic drug, in volunteers. Int J Clin Pharmacol Biopharm 16: 570-574
5. Desager JP, Hulhoven R, Harvengt C 1980 Uricosuric effect of fenofibrate in healthy volunteers. J Clin Pharmacol 10: 560-564
6. Diletti E, Hauschke D, Steinijans VW 1991 Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 29: 1-8
7. Hauschke D, Steinijans VW, Diletti E, Schall R, Luus HG, Elze M, Blume M 1994 Presentation of the intrasubject coefficient of variation for sample size planning in bioequivalence studies. Int J Clin Pharmacol Ther 32: 376-378
8. Schulz H-U, Steinijans VW 1991 Striving for standards in bioequivalence assessment: a review. Int J Clin Pharmacol Ther Toxicol 29: 193-298
9. Steinijans VW, Sauter R, Hauschke D, Diletti E, Schall R, Luus HG, Elze M, Blume H, Hoffmann C, Franke G, Siegmund W 1995 Reference tables for the intrasubject coefficient of variation in bioequivalence studies. Int J Clin Pharmacol Ther 33: 427-430
10. 14C-fenofibrate in human plasma. Acta Pharmacol Toxicol 59 (Suppl 5): 167