Bioequivalence and pharmacokinetic evaluation of two branded formulations of aceclofenac 100 mg: a single-dose, randomized, open-label, two-period crossover comparison in healthy Korean adult volunteers

Clinical Therapeutics

Volumn 30, Issue 4, 2008, Pages 633-640

  Rhim, Si Youn ^a   Park, Jin Hee ^b   Park, Yoo Sin ^b   Lee, Min Ho ^c   Shaw, Leslie M ^d   Kang, Ju Seop ^b  

^a Department of Biochemistry and Molecular Biology   (South Korea)

^b Konkuk University School of Medicine   (South Korea)

^c Hanyang University College of Medicine   (South Korea)

^d Department of Surgery   (United States)

Author keywords

aceclofenac; bioequivalence test; HPLC method.; pharmacokinetics,

Indexed keywords

ACECLOFENAC; APONAC; KETOPROFEN; WATER;

ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOATING; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG BIOAVAILABILITY; DRUG FORMULATION; FATIGUE; FEMALE; HEADACHE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; KOREA; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; PHARMACOKINETICS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STOMACH PAIN; TABLET FORMULATION; VOMITING;

EID: 43549092374     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2008.04.008     Document Type: Article

References (22)

1. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations [US Food and Drug Administration (FDA) Web site].
2. http://www.fda.gov/cder/guidance/5356fnl.pdf March 18, 2007 Accessed
3. G Pasero R Marcolongo U Serni A multi-centre, double-blind comparative study of the efficacy and safety of aceclofenac and diclofenac in the treatment of rheumatoid arthritis Curr Med Res Opin 13 1995 305 315
4. MJ O'Neil B Susan The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th ed 2001 Merck & Co, Inc Whitehouse Station, NJ
5. 2 production following its intracellular conversion into cyclooxygenase inhibitors Eur J Pharmacol 329 1997 181 187
6. CS Sean Martindale: The Extra Pharmacopoeia. 2005 Pharmaceutical Press Chicago, Ill 67
7. British National Formulary (BNF) 36th ed 1998 British Medical Association and the Royal Pharmaceutical Society of Great Britain London, UK
8. G Torri Efficacy and tolerability of aceclofenac in the treatment of gonalgia: Controlled double-blind study vs diclofenac Curr Ther Res Clin Exp 42 1987 453 457
9. G Giorgianni C Ottaviani A Soliano N Campi Efficacy and tolerability of aceclofenac versus ketoprofen in the treatment of rheumatoid arthritis Curr Ther Res Clin Exp 51 1992 175 184
10. RN Brogden LR Wiseman Aceclofenac. A review of its pharmacodynamic properties and therapeutic potential in the treatment of rheumatic disorders and in pain management Drugs 52 1996 113 124
11. J Honorato R Caballero G Giorgianni Dose-analgesic response study and aceclofenac plasma levels in humans Curr Ther Res Clin Exp 47 1990 605 611
12. The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit, International Conference on Harmonisation. Guideline for Good Clinical Practice [EMEA Web site].
13. http://www.emea.eu.int March 26, 2007 Accessed
14. N Najib N Idkaidek M Beshtawi Bioequivalence evaluation of two brands of aceclofenac 100 mg tablets (Aceclofar and Bristaflam) in healthy human volunteers Biopharm Drug Dispos 25 2004 103 108
15. B Koçyigit-Kaymakçoglu S Unsalan S Rollas Determination and validation of ketoprofen, pantoprazole and valsartan together in human plasma by high performance liquid chromatography Pharmazie 61 2006 586 589
16. B Hinz D Auge T Rau Simultaneous determination of aceclofenac and three of its metabolites in human plasma by high-performance liquid chromatography Biomed Chromatogr 17 2003 268 275
17. RC Shumaker PKCALC: A BASIC interactive computer program for statistical and pharmacokinetic analysis of data Drug Metab Rev 17 1986 331 348
18. FDA Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products. Rockville, Md: Office of Generic Drugs, Division of Bioequivalence, US Food and Drug Administration; 2003.
19. S-C Chow J-P Liu Design and Analysis of Bioavailability and Bioequivalence Studies. 1992 Marcel Dekker Inc New York, NY
20. KV Gowda DS Rajan U Mandal Evaluation of bioequivalence of two formulations containing 100 milligrams of aceclofenac Drug Dev Ind Pharm 32 2006 1219 1225
21. C Martínez G Blanco E Garcá-Martń JA Agúndez Clinical pharmacogenomics for CYP2C8 and CYP2C9: General concepts and application to the use of NSAIDs [in Spanish] Farm Hosp 30 2006 240 248
22. YM Kim SH Yoo RY Kang Identifying drugs needing pharmacogenetic monitoring in a Korean hospital Am J Health Syst Pharm 64 2007 166 175