Bioavailability and pharmacokinetic comparison between generic and branded azithromycin capsule: A randomized, double-blind, 2-way crossover in healthy male thai volunteers

Clinical Therapeutics

Volumn 29, Issue 4, 2007, Pages 703-710

  Boonleang, Jutima ^a   Panrat, Kamon ^a   Tantana, Chanpa ^a   Krittathanmakul, Siriporn ^a   Jintapakorn, Worawut ^a  

^a PRINCE OF SONGKLA UNIVERSITY   (Thailand)

Author keywords

azithromycin; bioequivalence; pharmacokinetics

Indexed keywords

9 FLUORENYLMETHYLOXYCARBONYL; AZITHROMYCIN; CARBONYL DERIVATIVE; FLOCTIL; FLUORENE DERIVATIVE; GENERIC DRUG; UNCLASSIFIED DRUG;

ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DERIVATIZATION; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG FORMULATION; DRUG TOLERABILITY; FLUORESCENCE; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE; THAILAND; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT;

ADULT; ANALYSIS OF VARIANCE; ANTI-BACTERIAL AGENTS; AZITHROMYCIN; BIOLOGICAL AVAILABILITY; CAPSULES; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; HUMANS; MALE; THAILAND; THERAPEUTIC EQUIVALENCY;

EID: 34347371457     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2007.04.010     Document Type: Article

References (27)

1. In: McEvoy G.K. (Ed). AHFS Drug Information 2005 224 (2005), American Society of Health System Pharmacists, Bethesda, Md 233-247
2. Kapusnik-Uner J.E., Sande M.A., and Chambers H.F. Antimicrobial agents. In: Hardman J.G., and Limbird L.E. (Eds). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. (1996), McGraw-Hill Health Professions Division, New York, NY 1135-1140
3. Dunn C.J., and Barradell L.B. Azithromycin. A review of its pharmacological properties and use as 3-day therapy in respiratory tract infections. Drugs 51 (1996) 483-505
4. Peters D.H., Friedel H.A., and McTavish D. Azithromycin. A review of its antimicrobial activity, pharmacokinetic properties and clinical efficacy. Drugs 44 (1992) 750-799
5. Drew R.H., and Gallis H.A. Azithromycin-spectrum of activity, pharmacokinetics, and clinical applications. Pharmacotherapy 12 (1992) 161-173
6. Langtry H.D., and Balfour J.A. Azithromycin. A review of its use in paediatric infectious diseases. Drugs 56 (1998) 273-297
7. Wise R. The pharmacokinetics of azithromycin. Rev Contemp Pharmacother 5 (1994) 329-340
8. Foulds G., Shepard R.M., and Johnson R.B. The pharmacokinetics of azithromycin in human serum and tissues. J Antimicrob Chemother 25 Suppl A (1990) 73-82
9. Cooper M.A., Nye K., Andrew J.M., and Wise R. The pharmacokinetics and inflammatory fluid penetration of orally administered azithromycin. J Antimicrob Chemother 26 (1990) 533-538
10. In: Ritschel W.A., and Kearns G.L. (Eds). Handbook of Basic Pharmacokinetics-Including Clinical Applications. 5th ed. (1999), American Pharmaceutical Association, Washington, DC 479-503
11. Foulds G., Luke D.R., Teng R., et al. The absence of an effect of food on the bioavailability of azithromycin administered as tablets, sachet or suspension. J Antimicrob Chemother 37 Suppl C (1996) 37-44
12. Luke D.R., and Foulds G. Disposition of oral azithromycin in humans. Clin Pharmacol Ther. 61 (1997) 641-648
13. Garey K.W., Peloquin C.A., Godo P.G., et al. Lack of effect of zafirlukast on the pharmacokinetics of azithromycin, clarithromycin, and 14-hydroxyclarithromycin in healthy volunteers. Antimicrob Agents Chemother 43 (1999) 1152-1155
14. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects [WMA Web site]. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964 (2006). http://www.wma.net/e/policy/b3.htm
15. European Agency for the Evaluation of Medicinal Products, International Conference on HarmonisationWorld Health Organization. Guideline for Good Clinical Practice [EMEA Web site]. ICH Topic E6 (2002), WHO, Geneva, Switzerland. http://www.emea.eu.int Accessed June 20, 2006
16. The United States Pharmacopeia 27: The National Formulary 22 [CDROM] (2004), The United States Pharmacopeial Convention, Inc, Rockville, Md
17. Thailand Guidelines for the conduct of bioavailability and bioequivalence studies (2005), Drug Control Division, Food and Drug Ad ministration, Ministry of Public Health, Bangkok, Thailand. http://www.fda.moph.go.th
18. Available at:. Association of Southeast Asian Nations (ASEAN), and Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group. Guidelines for the conduct of bioavailability and bioequivalence studies. AccessedJune 20, 2006 (2004). http://www.fda.moph.go.th
19. Sastre Torano J., and Guchelaar H.J. Quantitative determination of the macrolide antibiotics erythromycin, roxithromycin, azithromycin and clarithromycin in human serum by highperformance liquid chromatography using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride and fluorescence detection. J Chromatogr B Biomed Sci Appl. 720 (1998) 89-97
20. Available at:. Guidance for Industry. Bioanalytical method validation [CIDER Web site]. Accessed January 14, 2003 (2001), US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Center for Veterinary Medicine, Washington, DC. http://www.fda.gov/cder/guidance/index.htm
21. Bolton S. Pharmaceutical Statistics: Practical and Clinical Applications. 3rd ed. (1997), Marcel Dekker, New York, NY 405-418
22. Yuh L. Statistical consideration for bioavailability/bioequivalence studies. In: Welling P.G., and Tse Francis L.S. (Eds). Pharmacokinetics. 2nd ed (1995), Marcel Dekker, New York, NY 479-502
23. Schuirmann D.J. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15 (1987) 657-680
24. Available at. Guidance for Industry. Statistical approaches to establishing bioequivalence [CIDER Web site]. Accessed February 7, 2003 (January 2001), US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Washington, DC. http://www.fda.gov/cder/guidance/index.htm
25. Pineyro-Lopes A., Pineyro-Garza E., Torres-Alanis O., et al. Bioavailability of two oral formulations of azith romycin 500 mg: A randomized, open-label, two-period crossover comparison in healthy Mexican adult subjects. Clin Ther. 27 (2005) 1607-1611
26. Najib N.M., Idkaidek N., Ghanem I.E., et al. Bioequivalence assessment of Azomycin (Julphar, UAE) as com pared to Zithromax (Pfizer, USA)two brands of azithromycin-in healthy human volunteers. Biopharm Drug Dispos 22 (2001) 15-21
27. Gulati R., Tripathi C.D., and Chandra D. Comparative bioavailability of two formulations of azithromycin. J Assoc Physicians India. 48 (2000) 606-608