Bioequivalence and pharmacokinetics of two zidovudine formulations in healthy brazilian volunteers: An open-label, randomized, single-dose, two-way crossover study

Clinical Therapeutics

Volumn 30, Issue 5, 2008, Pages 902-908

  dos Reis Serra, Cristina Helena ^a   Mori Koono, Eunice Emiko ^a   Kano, Eunice Kazue ^a   Schramm, Simone Grigoleto ^a   Armando, Yara Popst ^a   Porta, Valentina ^a  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

bioequivalence; chromatography.; high performance liquid; human plasma; pharmacokinetic; zidovudine

Indexed keywords

GENERIC DRUG; ZIDOVUDINE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; BRAZIL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSAGE FORM COMPARISON; DRUG ELIMINATION; DRUG FORMULATION; FEMALE; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; VOLUNTEER;

ADULT; ANTI-HIV AGENTS; CROSS-OVER STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; REVERSE TRANSCRIPTASE INHIBITORS; THERAPEUTIC EQUIVALENCY; ZIDOVUDINE;

EID: 44849114302     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2008.05.003     Document Type: Article

References (32)

1. De Clercq E. Emerging anti-HIV drugs. Exp Opin Emerg Drugs 10 (2005) 241-273
2. De Clercq E. Antiviral drugs in current clinical use. J Clin Virol 30 (2004) 115-133
3. Nucleoside and nucleotide reverse transcriptase inhibitors. In: McEvoy G. (Ed). AHFS Drug Information 2005. (2005), American Society of Health-System Pharmacists, Bethesda Md 735-749
4. Acosta E., Page L., and Fletcher C. Clinical pharmacokinetics of zidovudine. An Update. Clin Pharmacokinet 30 (1996) 251-262
5. Lotterer B., Ruhnke M., and Trautmann M. Decreased and variable systemic availability of zidovudine in patients with AIDS if administered with a meal. Eur J Clin Pharmacol 40 (1991) 305-308
6. Unadkat J., Collier A., and Crosby S. Pharmacokinetics of oral zidovudine (azidothymidine) in patients with AIDS when administered with and without a high-fat meal. AIDS 4 (1990) 229-232
7. King J., Kimberlin D., Aldrovandi G., and Acosta E. Antiretroviral pharmacokinetics in the pediatric population: A review. Clin Pharmacokinet 41 (2002) 1115-1133
8. Do Nascimento J., Magalhães N., Ribeiro R., et al. Pharmacokinetic evaluation of lamivudine and zidovudine tablets in human plasma. Braz J Pharm Sci 40 (2004) 59-66
9. Brazil Ministry of Health. National AIDS Drug Policy (2006), Coordenação Nacional de DST e AIDS, Ministério da Saúde, Brasília, Brazil
10. Galvão J. Access to antiretroviral drugs in Brazil. Lancet 360 (2002) 1862-1865
11. Shargel L., and Yu A. Applied Biopharmaceutics and Pharmacokinetics. 3rd ed (1993), Appleton & Lange, Norwalk, Conn
12. Van Schoen Angerer T., Wilson D., Ford N., and Kasper T. Access and activism: The ethics of providing antiretroviral therapy in developing countries. AIDS 15 Suppl 5 (2001) S81-S90
13. Pharmacokinetic considerations in bioavailability studies. In: Abdou H. (Ed). Dissolution, Bioavailability and Bioequivalence. (1989), Mack Printing, Easton, Pa 335-366
14. Chow S.-C., and Liu J.-P. Design and Analysis of Bioavailability and Bioequivalence Studies. 2nd ed (2000), Marcel Dekker, New York, NY
15. Blum R., Liao S., Good S., and de Miranda P. Pharmacokinetics and bioavailability of zidovudine in humans. Am J Med 85 (1988) 189-194
16. Morse G., Shelton M., Ho M., et al. Pharmacokinetics of zidovudine and didanosine during combination therapy. Antiviral Res 27 (1995) 419-424
17. Yuen G., Lou Y., Thompson N., et al. Abacavir/lamivudine/ zidovudine as a combined formulation tablet: Bioequivalence compared with each component administered concurrently and the effect of food on absorption. J Clin Pharmacol 41 (2001) 277-288
18. Moore K., Shaw S., Laurent A., et al. Lamivudine/zidovudine as a combined formulation tablet: Bioequivalence compared with lamivudine and zidovudine administered concurrently and the effect of food on absorption. J Clin Pharmacol 39 (1999) 593-605
19. Vezina H., Henry K., Ravindran G., et al. A randomized crossover study to determine bioequivalence of generic and brand name nevirapine, zidovudine, and lamivudine in HIV-negative women in India. J Acquir Immune Defic Syndr 41 (2006) 131-136
20. Good S., Reynolds D., and de Miranda P. Simultaneous quantification of zidovudine and its glucuronide in serum by high-performance liquid chromatography. J Chromatogr 431 (1988) 123-133
21. Zhou Y., Shi Q., Liang Y., et al. Pharmacokinetics and bioequivalence of zidovudine capsule in healthy volunteers. Zhongguo Linchuang Yaolixue Zazhi 21 (2005) 355-358
22. Marier J., Manthos H., Kebir S., et al. Comparative bioavailability study of zidovudine administered as two different tablet formulations in healthy capsule in healthy adult subjects. Int J Clin Pharmacol Ther 44 (2006) 240-246
23. BRASIL. Resolução RE n.1170. A Agência Nacional de Vigilância Sanitária-ANVISA. Guia para provas de biodisponibilidade e bioequivalência de medicamentos. Diário Oficial da União, Brasília, 2006.
24. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER).Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, 2002 [FDA Web site].
25. (January 28, 2008). http://www.fda.gov/cder/guidance/4964dft.htm Accessed
26. Kano E., dos Reis Serra C., Koono E., et al. Determination of lamivudine in human plasma by HPLC and its use in bioequivalence studies. Int J Pharm 297 (2005) 73-79
27. BRASIL. Resolução RE n.899. A Agência Nacional de Vigilância Sanitária-ANVISA. Guia para validação de métodos analíticos e bioanalíticos. Diário Oficial da União, Brasília, 2003.
28. Ritschel W. Handbook of Basic Pharmacokinetics. 4th ed (1992), Drug Intelligence Publications, Hamilton, Ill
29. LeBlanc P., Aiache J., and Besner J. Tratado de Biofarmácia e Farmacocinética (1997), Piaget Institute, Lisbon, Portugal
30. Zala C., Alexander C., Ochoa C., et al. Comparable pharmacokinetics of generic indinavir (Inhibisam) versus brand indinavir (Crixivan) when boosted with ritonavir. J Acquir Immune Defic Syndr 38 (2005) 363-364
31. Singlas E., Pioger J., Taburet A., et al. Comparative pharmacokinetics of zidovudine (AZT) and its metabolite (G.AZT) in healthy subjects and HIV seropositive patients. Eur J Clin Pharmacol 36 (1989) 639-640
32. Yang B., Ma L., Qi H., et al. Studies on bioequivalence of zidovudine capsule in healthy volunteers. Chinese Pharm J 40 (2005) 1097-1099