Clinical trial NCT02604004 - References

HIV INFECTIONS — Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet of 150 mg in Healthy Volunteers

Citation(s)

•   ANVISA
  "Guia para planejamento e realização da etapa estatística de estudos de Biodisponibilidade relativa / Bioequivalência". RE Nº. 898, de 29 de maio de 2003.
•   ANVISA
  Manual de Boas Práticas em Biodisponibilidade/ Bioequivalência. Volume I. Agência Nacional de Vigilância Sanitária. Brasília: ANVISA, 2002.
•   ANVISA
  Resolução RE nº 1170, de 19 de abril de 2006. "Guia para provas de biodisponibilidade relativa/ bioequivalência de medicamentos". ANVISA-MS, Brasília.
•   ANVISA
  Resolução RE nº 899, de 29 de maio de 2003. "Guia para validação de métodos analíticos e bioanalíticos". ANVISA-MS, Brasília.
•   Bigos KL, Pollock BG, Stankevich BA, Bies RR
  Sex differences in the pharmacokinetics and pharmacodynamics of antidepressants: an updated review. Gend Med. 2009 Dec;6(4):522-43. doi: 10.1016/j.genm.2009.12.004. Review.
•   Center for Drug Evaluation and Research, US Food and Drug Administration
  Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations [COER Web site). http://www.fda.gov/cder/guidance/5356
•   EMEA (European Agency for the Evaluation of Medicinal Products)
  CPMP (Committee for Propietary Medicinal Products). Note for guidance on the investigation of bioavailability and bioequivalence. London, July 2001.
•   FLOCKHART D
  A. Drug interactions: Cytochrome P450 drug interaction table. Indiana School of Medicine. 2007. http://medicine.iupui.edu/clinpharm/ddis/ table.asp. Accessed December 1, 2009.
•   Goodman & Gilman's The Pharmacologic Basis of Therapeutics - 11th Ed
  (2006)
•   Greenblatt DJ, Divoll M, Harmatz JS, Shader RI
  Oxazepam kinetics: effects of age and sex. J Pharmacol Exp Ther. 1980 Oct;215(1):86-91.
•   http://www4
  anvisa.gov.br/base/visadoc/BM/BM[25676-1-0].PDF acessado em 13/10/2011.
•   Johnson MA, Moore KH, Yuen GJ, Bye A, Pakes GE
  Clinical pharmacokinetics of lamivudine. Clin Pharmacokinet. 1999 Jan;36(1):41-66. Review.
•   Kano EK, dos Reis Serra CH, Koono EE, Andrade SS, Porta V
  Determination of lamivudine in human plasma by HPLC and its use in bioequivalence studies. Int J Pharm. 2005 Jun 13;297(1-2):73-9. Epub 2005 Apr 26.
•   Martindale The Complete Drug Reference - Thirty-sixth edition (2009)
  
•   Narang VS, Lulla A, Malhotra G, Purandare S
  Pharmacokinetic profiling and bioequivalence evaluation of 2 lamivudine tablet formulations after single oral administration in healthy human Indian volunteers. J Acquir Immune Defic Syndr. 2005 Apr 15;38(5):56
•   Ofotokun I, Chuck SK, Hitti JE
  Antiretroviral pharmacokinetic profile: a review of sex differences. Gend Med. 2007 Jun;4(2):106-19. Review.
•   Perry CM, Faulds D
  Lamivudine. A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection. Drugs. 1997 Apr;53(4):657-80. Review.
•   Pluda JM, Cooley TP, Montaner JS, Shay LE, Reinhalter NE, Warthan SN, Ruedy J, Hirst HM, Vicary CA, Quinn JB, et al
  A phase I/II study of 2'-deoxy-3'-thiacytidine (lamivudine) in patients with advanced human immunodeficiency virus infection. J Infect Dis
•   Schwartz JB
  The influence of sex on pharmacokinetics. Clin Pharmacokinet. 2003;42(2):107-21. Review. Erratum in: Clin Pharmacokinet. 2004;43(11):732.
•   van Leeuwen R, Katlama C, Kitchen V, Boucher CA, Tubiana R, McBride M, Ingrand D, Weber J, Hill A, McDade H, et al
  Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infe
•   Wald A, Van Thiel DH, Hoechstetter L, Gavaler JS, Egler KM, Verm R, Scott L, Lester R
  Gastrointestinal transit: the effect of the menstrual cycle. Gastroenterology. 1981 Jun;80(6):1497-500.
•   World Medical Association Declaration of Helsinki (WMA)
  Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 52nd WMA General Assembly, Edinburgh, Sco

Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet 150 mg (Test) and EPIVIR of Glaxosmithkline in Healthy Volunteers of Both Genders in Fasting Condition

Details for clinical trial NCT02604004