Bioequivalence of pravastatin tablet formulations assessed in Korean males

International Journal of Clinical Pharmacology and Therapeutics

Volumn 42, Issue 5, 2004, Pages 301-306

  Bae, S K ^a   Kim, E J ^a   Lim, C H ^b   Lee, J S ^b   Kim, Y G ^b   Lee, M G ^a  

^a Seoul National University   (South Korea)

^b Dankook University   (South Korea)

Author keywords

Bioequivalence study; Pravastatin; Volunteers

Indexed keywords

PRAVASTATIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CALCULATION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG FORMULATION; DRUG MONITORING; DRUG TOLERABILITY; ETHNOLOGY; FOOD AND DRUG ADMINISTRATION; GENDER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; KOREA; LINEAR SYSTEM; MALE; NORMAL HUMAN; PRESCRIPTION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STANDARD; TABLET; VARIANCE; VOLUNTEER;

EID: 2542454739     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP42301     Document Type: Article

References (21)

1. Chiou WL 1978 Critical evaluation of the potential error in pharmacokinetic studies using the linear trapezoidal rule method for the calculation of the area under the plasma level-time curve. J Pharmacokinet Biopharm 6: 539-546
2. 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
3. Hatanaka T 2000 Clinical pharmacokinetics of pravastatin: mechanisms of pharmacokinetic events. Clin Pharmacokinet 39: 397-412
4. 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
5. Hsiang B, Zhu Y, Wang Z, Wu Y, Sasseville V, Yang WP, Kirchgessner TG 1999 A novel human hepatic organic anion transporting polypeptide (OATP2). Identification of a liver-specific human organic anion transporting polypeptide and identification of rat and human hydroxymethylglutaryl-CoA reductase inhibitor transporters. J Biol Chem 274: 37161-37168
6. Kantola T, Backman JT, Niemi M, Kivistö KT, Neuvonen PJ 2000 Effect of fluconazole on plasma fluvastatin and pravastatin concentrations. Eur J Clin Pharmacol 56: 225-229
7. Kyrklund C, Backman JT, Neuvonen M, Neuvonen PJ 2003 Gemfibrozil increases plasma pravastatin concentrations and reduces pravastatin renal clearance. Clin Pharmacol Ther 73: 538-544
8. Lee YJ, Choi JH, Song SH, Seo CH, Kim DS, Park IS, Choi KH, Na HK, Chung SJ, Lee MH, Shim C-K 1999 Development of K-BEtest, a computer program for the analysis of bioequivalence. J Korean Pharm Sci 28: 223-229
9. Mazzu AL, Lasseter KC, Shamblen EC, Agarwal V Lettieri J, Sundaresen P 2000 Itraconazole alters the pharmacokinetics of atorvastatin to a greater extent than either cerivastatin or pravastatin. Clin Pharmacol Ther 68: 391-400
10. Nakaya N, Homma Y, Tamachi H, Shigematsu H, Hata Y, Goto Y 1987 The effect of CS-514 on serum lipids and apolipoproteins in hypercholesterolemic subjects. JAMA 257: 3088-3093
11. Nishizato Y, Ieiri I, Suzuki H, Kimura M, Kawabata K, Hirota T, Takane H, Irie S, Kusuhara H, Urasaki Y, Urae A, Higuchi S, Otsubo K, Sugiyama Y 2003 Polymorphisms of OATP-C (SLC21A6) and OAT3 (SLC22A8) genes: consequences for pravastatin pharmacokinetics. Clin Pharmacol Ther 73: 554-565
12. Otter K, Mignat C 1998 Determination of pravastatin in human plasma by high-performance liquid chromatography with ultraviolet detection. J Chromatogr B 708: 235-241
13. Pan HY, Willard DA, Funke PT, McKinstry DN 1987 The clinical pharmacology of SQ 31,000 (CS 514) in healthy subjects. In: Paoletti R, Kritchevsky D, Holmes WL (eds) Drugs Affecting Lipid Metabolism. Springer, Berlin, pp 255-259
14. Pan HY, Triscari J, De Vault AA, Smith SA, Wang-Iverson D, Swanson BN, Willard DA 1991 Pharmacokinetic interaction between propranolol and the HMG-CoA reductase inhibitors pravastatin and lovastatin. Br J Clin Pharmacol 31: 665-670
15. Pan HY, Waclawski AP, Funke PT, Whigan D 1993 Pharmacokinetics of pravastatin in elderly versus young men and women. Ann Pharmacother 27: 1029-1033
16. Sauter R, Steinijans VW, Diletti E, Bohm A, Schulz HU 1992 Presentation of results from bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 30:233-256
17. Siekmeier R, Gross W, Marz W 2000 Determination of pravastatin by high performance liquid chromatography. Int J Clin Pharmacol Ther 38: 419-425
18. Singhvi SM, Pan HY, Morrison RA, Willard DA 1990 Disposition of pravastatin sodium, a tissue-selective HMG-CoA reductase inhibitor, in healthy subjects. Br J Clin Pharmacol 29: 239-243
19. Sugimoto K, Ohmori M, Tsuruoka S, Nishiki K, Kawaguchi A, Harada K, Arakawa M, Sakamoto K, Masada M, Miyamori I, Fujimura A 2001 Different effects of St John's wort on the pharmacokinetics of simvastatin and pravastatin. Clin Pharmacol Ther 70: 518-524
20. Tsujita Y, Kuroda M, Shimada Y, Tanzawa K, Arai M, Kaneko I, Tanaka M, Masuda H, Tarumi C, Watanabe Y, Fujii S 1986 CS-514, a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase: Tissue-selective inhibition of sterol synthesis and hypolipidemic effect on various animal species. Biochim Biophys Acta 877: 50-60
21. Witztum JL 1996 Drugs used in the treatment of hyperlipoproteinemias. In: Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, Goodman Gilman AG (eds) Goodman and Gilman's The Pharmacological Basis of Therapeutics (9th ed). McGraw-Hill, New York, pp 884-887