Bioequivalence of abacavir generic and innovator formulations under fasting and fed conditions

International Journal of Clinical Pharmacology and Therapeutics

Volumn 44, Issue 6, 2006, Pages 284-291

  Marier, J F ^a   Borges, M ^a   Plante, G ^a   DiMarco, M ^a   Morelli, G ^a   Tippabhotla, S K ^b   Vijan, T ^b   Singla, A K ^b   Garg, M ^b   Monif, Tausif ^b  

^a MDS Inc   (Canada)

^b RANBAXY LABORATORIES LTD   (India)

Author keywords

Abacavir; Bioequivalence; Healthy volunteers

Indexed keywords

ABACAVIR; GENERIC DRUG; RANBAXY ABACAVIR;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD ANALYSIS; BLOOD SAMPLING; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DIETARY INTAKE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; EYE TOXICITY; FLATULENCE; FOOD DRUG INTERACTION; GASTROINTESTINAL TOXICITY; HEADACHE; HUMAN; LIQUID CHROMATOGRAPHY; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; MASS SPECTROMETRY; MUSCULOSKELETAL DISEASE; NEUROTOXICITY; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

EID: 33744961187     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP44284     Document Type: Article

References (18)

1. Becher F, Landman R, Mboup S, Kane CN, Canestri A, Liegeois F, Vray M, Prevot MH, Leleu G, Benech H. Monitoring of didanosine and stavudine intracellular triphosphorylated anabolite concentrations in HIV-infected patients. AIDS. 2004; 18: 181-187.
2. Center for Drug Evaluation and Research. Ziagen (Abacavir Sulfate) Tablets and Oral Solution, Application No.: 20-977 and 20-978 Available at http://www.fda.gov/cder/foi/nda/98/20-977_Ziagen.htm.
3. Chittick GE, Gillotin C, McDowell JA, Lou Y, Edwards KD, Prince WT, Stein DS. Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food. Pharmacotherapy 1999; 19: 932-942.
4. Cvetkovic RS, Goa KL. Lopinavir/ritonavir: a review of its use in the management of HIV infection. Drugs. 2003; 63: 769-802.
5. Dybul M, Fauci AS, Bartlett JG, Kaplan JE, Pau AK. Panel on Clinical Practices for Treatment of HIV. Guidelines for using antiretroviral agents among HIV-infected adults and adolescents. Ann Intern Med. 2002; 137: 381-433.
6. Fletcher CV, Kawle SP, Kakuda TN, Anderson PL, Weller D, Bushman LR, Brundage RC, Remmel RP. Zidovudine triphosphate and lamivudine triphosphate concentration-response relationships in HIV-infected persons. AIDS. 2000; 14: 2137-2144.
7. Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. Available at http://www.fda.gov/cder/guidance/5356-fnl.pdf.2003.
8. Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990; 28: 72-78.
9. Hervey PS, Perry CM. Abacavir: a review of its clinical potential in patients with HIV infection. Drugs. 2000; 60: 447-479.
10. Kaplan SS, Hicks CB. Safety and antiviral activity of lopinavir/ ritonavir-based therapy in human immunodeficiency virus type 1 (HIV-1) infection. J Antimicrob Chemother. 2005; 56: 273-276.
11. Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998; 338: 853-860.
12. Pozniak A, Gazzard B, Anderson J, Babiker A, Churchill D, Collins S, Fisher M, Johnson M, Khoo S, Leen C, Loveday C, Moyle G, Nelson M, Peter B, Phillips A, Pillay D, Wilkins E, Williams I, Youle M. BHIVA Writing Committee BHIVA Executive Conunittee. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. HIV Med. 2003; 4 (Suppl 1): 1-41.
13. Rowland M, Towzer TN. Clinical Pharmacokinetics: Concepts and Application (3rd edition, Chap. 21). Media, PA: Lippincott Williams and Wilkins; 1995. pp. 367-393.
14. Saez-Llorens X, Nelson RP Jr, Emmanuel P, Wiznia A, Mitchell C, Church JA, Sleasman J, Van Dyke R, Richardson CG, Cutrell A, Spreen W, Hetherington S. A randomized, double-blind study of triple nucleoside therapy of abacavir, lamivudine, and zidovudine versus lamivudine and zidovudine in previously treated human immunodeficiency virus type 1-infected children. The CNAA3006 Study Team. Pediatrics. 2001; 107: E4.
15. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987; 15: 657-680.
16. Staszewski S, Keiser P, Montaner J, Raffi F, Gathe J, Brotas V, Hicks C, Hammer SM, Cooper D, Johnson M, Tortell S, Cutrell A, Thorborn D, Isaacs R, Hetherington S, Steel H, Spreen W, CNAAB3005 International Study Team. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: a randomized equivalence trial. JAMA. 2001; 285: 1155-1163.
17. Stein DS, Moore KH. Phosphorylation of nucleoside analog antiretrovirals: a review for clinicians. Pharmacotherapy. 2001; 21: 11-34.
18. The EMEA Note for Guidance on the Investigation of Bioavailability and Bioequivalence. Available at www.emea.eu.int/pdfs/human/ewp/140198en.pdf. 2001.