Bioequivalence of allopurinol-containing tablet preparations

International Journal of Clinical Pharmacology and Therapeutics

Volumn 37, Issue 3, 1999, Pages 148-152

  Barthel, W ^a   Huller G ^a   Haustein, K O ^a  

^a FRIEDRICH SCHILLER UNIVERSITY JENA   (Germany)

Author keywords

Allopurinol; Bioavailability; Bioequivalence; Oxypurinol tablet formulation; Volunteers

Indexed keywords

ALLOPURINOL; OXIPURINOL; UNCLASSIFIED DRUG; URIBENZ; URIC ACID;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL; TABLET FORMULATION;

ADMINISTRATION, ORAL; ADULT; ALLOPURINOL; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; FEMALE; GOUT SUPPRESSANTS; HUMANS; LINEAR MODELS; MALE; OXYPURINOL; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 0344609319     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. Barthel W, Böhm C, Hüller G, Haustein K-O 1997 Bioequivalence of tolbutamide-containing tablet preparations. Int J Clin Pharmacol Ther Toxicol 35: 43-46
2. Blume H, Kübel-Thiel K, Reutter B, Siewert M, Stenzhorn G 1988 Nifedipin: Monographie zur Prüfung der Bioverfügbarkeit/Bioäquivalenz von schnell-freisetzenden Zubereitungen. Pharm Z 133: 389-393
3. Bührens K, Berndt P, Illgenstock CM, Baumann W, Janzen D 1991 Zum Nachweis der Bioäquivalenz von zwei Allopurinol-Präparaten. Drug Res 41: 250-253
4. Chen ML, Jackson AJ 1991 The role of metabolites in bioequivalency assessment. I. Linear pharmacokinetics without first-pass effect. Pharm Res 8: 25-32
5. Food and Drug Administration (FDA) 1977 Division of biopharmaceutics. Bioavailability protocol guidelines for ANDA and NDA submission. Washington
6. Hauschke D, Steinijans VW, Diletti E 1990 A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 28: 72-78
7. Jaeger H, Russmann D, Rasper J, Blome J 1982 Vergleichende Prüfung der Bioverfügbarkeit und des pharmakodynamischen Effektes von fünf Allopurinolzubereitungen. Drug Res 32: 438-443
8. Marcus M, Tse FLS, Kleinberg SI 1982 The bioavailability of two commercial preparations of allopurinol tablets. Int J Clin Pharmacol Ther Toxicol 20: 302-305
9. Murrell GAC, Rapeport WC 1986 Clinical pharmacokinetics of allopurinol. Clin Pharmacokinet 11: 343-353
10. Walter-Sack I, de Vries JX, Kreiner C, Ittensohn A, Stenzhorn G, Voss A, Weber E 1993 Bioequivalence of allopurinol preparations: to be assessed by the parent drug or the active metabolite? Clin Invest 71: 240-246