Bioequivalence evaluation of single doses of two tramadol formulations: A randomized, open-label, two-period. Crossover study in healthy brazilian volunteers.

Clinical Therapeutics

Volumn 32, Issue 4, 2010, Pages 758-765

  Silva, Marina de Freitas ^a   Schramm, Simone Grigoleto ^a   Kano, Eunice Kazue ^a   Koono, Eunice Emiko Mori ^a   Porta, Valentina ^a   dos Reis Serra, Cristina Helena ^a  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

Bioequivalence; HPLC; Human plasma; Pharmacokinetics; Quantification; Tramadol

Indexed keywords

GENERIC DRUG; TRAMADOL; TRAMALIV; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BRAZIL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MARKETING; DRUG MONITORING; DRUG TOLERABILITY; DRUG USE; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NORMAL HUMAN; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SOMNOLENCE; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; VOLUNTEER;

ADULT; ANALGESICS, OPIOID; ANALYSIS OF VARIANCE; AREA UNDER CURVE; BRAZIL; CROSS-OVER STUDIES; FEMALE; HALF-LIFE; HUMANS; MALE; METABOLIC CLEARANCE RATE; THERAPEUTIC EQUIVALENCY; TRAMADOL;

EID: 77952533864     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.03.016     Document Type: Article

References (27)

1. Lee CR, McTavish D, Sorkin EM Tramadol. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in acute and chronic pain states. Drugs 1993, 46:313-340.
2. Lofwall MR, Walsh SL, Bigelow GE, Strain EC Modest opioid withdrawal suppression efficacy of oral tramadol in humans. Psychopharmacology (Berl) 2007, 194:381-393.
3. Kubota R, Komiyama T, Miwa Y, et al. Pharmacokinetics and postoperative analgesia of epidural tramadol: A prospective, pilot study. Curr Ther Res Clin Exp 2008, 69:49-55.
4. Cnota PJ, Nowak H, Tagarro I, et al. Tramadol SR formulations: Pharmacokinetic comparison of a multiple-units dose (capsule) versus a single-unit dose (tablet). Clin Drug Investig 2005, 25:435-443.
5. Malonne H, Sonet B, Streel B, et al. Pharmacokinetic evaluation of a new oral sustained release dosage form of tramadol. Br J Gin Pharmacol 2004, 57:270-278.
6. Lintz W, Barth H, Osterloh G, Schmidt-Böthelt E Bioavailability of enteral tramadol formulations. 1st Communication: Capsules. Arzneimittelforschung 1986, 36:1278:1283.
7. Likar R, Wittels M, Molnar M, et al. Pharmacokinetic and pharmacodynamic properties of tramadol IR and SR in elderly patients: A prospective, age-group-controlled study. Clin Ther 2006, 28:2022-2039.
8. Giorgi M, Saccomanni G, Lebkowska-Wieruszewska B, Kowalski C Pharmacokinetic evaluation of tramadol and its major metabolites after single oral sustained tablet administration in the dog: A pilot study. Vet J 2009, 180:253-255.
9. Lewis KS, Han NH Tramadol: A new centrally acting analgesic. Am J Health Syst Pharm 1997, 54:643-652.
10. Grond S, Sablotzki A Clinical pharmacology of tramadol. Clin Pharmacokinet 2004, 43:879-923.
11. Lintz W, Barth H, Becker R, et al. Pharmacokinetics of tramadol and bioavailabihty of enteral tramadol formulations. 2nd Communication: Drops with ethanol. Arzneimittelforschung 1998, 48:436-445.
12. Shargel L, Yu AB Applied Biopharmaceuties and Pharmacokinetics 1999, Appleton & Lange, Norwalk, Conn. 4th ed.
13. Dos Reis Serra CH, Mori Koono EE, Kano EK, et al. Bioequivalence and pharmacokinetics of two zidovudine formulations in healthy Brazilian volunteers: An open-label, randomized, single-dose, two-way crossover study. Clin Ther 2008, 30:902-908.
14. US Dept of Health & Human Services, US Food and Drug Administration. CFR - Code of Federal Regulations. Title 21: Food and drugs. Subchapter D: Drugs for human use. Part 320: Bioavailability and bioequivalence requirements, 2009. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=320&howFR=1 Accessed February 22, 2010.
15. Abdou HM Dissolution, Bioavailabi & Bioequivalence 1989, 554. Mack Publishing Co, Easton, Pa.
16. Chen ML, Shah V, Patnaik R, et al. Bioavailability and bioequivalence: An FDA regulatory overview. Pharm Res 2001, 18:1645-1650.
17. Korolkovas A Dicionário Terapêutico Guanabara 2008/2009 2008, Rio de Janeiro, Brazil.
18. de Sousa AB, Santos AC, Schramm SG, et al. Pharmacokinetics of tramadol and o-desmethyltramadol in goats after intravenous and oral admin istration. J Vet Pharmacol Ther 2008, 31:45-51.
19. World Medical Association. Declaration of Helsinki: Recommendations guiding physicians in bio medical research involving human subjects. http://www.wma.net/en/60about/70history/01declarationHelsinki/index.html Accessed January 31, 2010.
20. European Agency for the Evaluation of Medicinal Products (EMEA), International Conference on Har monisation, World Health Organization (WHO). Guideline for Good Clinical Practice. ICH Topic E 6 (R1). http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf Accessed January 31, 2010.
21. Ministério daúaude, Agência Nacional de Vigilância Sanitária. ANVISA. Visalegis. Resolution RE no. 1170, from April 19, 2006. Official Diary from Uniǎo, Brasília, April 24, 2006. Section 1. [The National Health Surveillance Agency (ANVISA approves a bioavailability and bioequivalence assay for drugs guide.]. http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=21746&word= Accessed January 31, 2010.
22. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. ANVISA. Visalegis. Resolution RE no. 899, from May 29, 2003. Official Diary from Uniǎo, Brasília, June 2, 2003. Section 1. [The National Health Surveillance Agency (ANVISA approves a validation guide for analytic and bioanalytic methods.]. http://e-legis.anvisa.gov.br/leisref/public/showAct.php?id=15132&word= Accessed Jan uary 31, 2010.
23. US Dept of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CIDER). Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug productsgeneral considerations, 2002. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugsApplicationANDAGenerics/UCM154838.pdf Accessed January 31, 2010.
24. Ritschel WA Handbook of Basic Pharmacokinetics-Including Clinical Applications 2004, Drug Intelligence Publications, Hamilton, Ill. 5th ed.
25. Chow S-C, Liu JP Statistical methods for average bioavailability. Design and Analysis of Bioavailability and Bioequiualence Studies 2000, 79-124. Marcel Dekker, New York, NY. 2nd ed.
26. Gan SH, Ismail R, Wan Adrian WA, Wan Z Method development and validation of a high-performance liquid chromatographic method for tramadol in human plasma using liquid-liquid extraction. J Chromatogr B Analyt Technol Biomed Life Sci 2002, 772:123-129.
27. Yeh GC, Shen MT, Yen CL, et al. High performance liquid chromatographic method for determination of tramadol in human plasma. J Chromatogr B Biomed Sci Appl 1999, 723:247-253.