Comparative bioavailability of a generic capsule formulation of the reverse transcriptase inhibitor efavirenz and the innovator product

International Journal of Clinical Pharmacology and Therapeutics

Volumn 44, Issue 4, 2006, Pages 180-184

  Marier, J F ^a   Morin, I ^a   Al Numani, D ^a   Stiles, M ^a   Morelli, G ^a   Tippabhotla, S K ^b   Vijan, T ^b   Singla, A K ^b   Garg, M ^b   Di Marco, M ^a   Monif, Tausif ^b  

^a MDS Inc   (Canada)

^b RANBAXY LABORATORIES LTD   (India)

Author keywords

Efavirenz; Healthy volunteers; Relative bioavailability

Indexed keywords

EFAVIRENZ; GENERIC DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSE REGIMEN; DRUG FORMULATION; DRUG HALF LIFE; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; NAUSEA; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; VOMITING;

EID: 33645744077     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP44180     Document Type: Article

References (14)

1. Anderson PL 2004 Pharmacologic perspectives for once-daily antiretroviral therapy. Ann Pharmacother 38: 1924-1934
2. Caro JJ, O'Brien JA, Migliaccio-Walle K, Raggio G 2001 Economic analysis of initial HIV treatment. Efavirenz- versus indinavir-containing triple therapy. Pharmacoeconomics 19: 95-104
3. Center for Drug Evaluation and Research 1998 Approval Date: 9/17/1998. Application Number 20-972. Sustiva Efavirenz 50, 100, and 200 mg capsules. Available at http://www.fda.gov/cder/foi/nda/98/20972.htm
4. Food and Drug Administration 2003 Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general considerations (March 2003). http://www.fda.gov/cder/guidance/5356fnl.pdf/13 June 2005
5. Fortin C, Joly V 2004 Efavirenz for HIV-1 infection in adults: an overview. Exp Rev Antiinfect Ther 2: 671-684
6. 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
7. Mouly S, Lown KS, Kornhauser D, Joseph JL, Fiske WD, Benedek IH, Watkins PB 2002 Hepatic but not intestinal CYP3A4 displays dose-dependent induction by efavirenz in humans. Clin Pharmacol Ther 72: 1-9
8. Mutlib AE, Chen H, Nemeth GA, Markwalder JA, Seitz SP, Gan LS, Christ DD 1999 Identification and characterization of efavirenz metabolites by liquid chromatography/mass spectrometry and high field NMR: species differences in the metabolism of efavirenz. Drug Metab Dispos 27: 1319-1333
9. Plosker GL, Perry CM, Goa KL 2001 Efavirenz: a pharmacoeconomic review of its use in HIV infection. Pharmacoeconomics 19: 421-436
10. Schuirmann DJ 1987 A comparison of the 2 one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15: 657-680
11. Smith PF, DiCenzo R, Morse GD 2001 Clinical pharmacokinetics of non-nucleoside reverse transcriptase inhibitors. Clin Pharmacokinet 40: 893-905
12. Torre D, Tambini R, Speranza F 2001 Nevirapine or efavirenz combined with two nucleoside reverse transcriptase inhibitors compared to HAART: a meta-analysis of randomized clinical trials. HIV Clin Trials 2: 113-121
13. The EMEA Note for Guidance on the Investigation of Bioavailability and Bioequivalence 2001 http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf 13 June 2005
14. Ward BA, Gorski JC, Jones DR, Hall SD, Flockhart DA, Desta Z 2003 The cytochrome P450 2B6 (CYP2B6) is the main catalyst of efavirenz primary and secondary metabolism: implication for HIV/AIDS therapy and utility of efavirenz as a substrate marker of CYP2B6 catalytic activity. J Pharmacol Exp Ther 306: 287-300