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JAC Advance Access published online on October 28, 2006
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkl445
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© The Author 2006. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org
Received July 26, 2006
Revised October 9, 2006
Accepted October 9, 2006

Original article

Pharmacokinetics of two generic fixed-dose combinations for HIV-infected children (Pedimune Baby & Pedimune Junior) are similar to the branded products in healthy adults

Rafaëlla F. A. L'homme 1 *, Tim Dijkema 2, Adilia Warris 3, Andre J. A. M. van der Ven 4, Diana M. Gibb 5, and David M. Burger 1

1 Department of Clinical Pharmacy, Radboud University Medical Centre, Nijmegen, The Netherlands; Nijmegen University Centre for Infectious Diseases (NUCI), Nijmegen, The Netherlands
2 Clinical Research Centre Nijmegen, Radboud University Medical Centre, Nijmegen, The Netherlands
3 Nijmegen University Centre for Infectious Diseases (NUCI), Nijmegen, The Netherlands; Department of Paediatrics, Radboud University Medical Centre, Nijmegen, The Netherlands
4 Nijmegen University Centre for Infectious Diseases (NUCI), Nijmegen, The Netherlands; Department of General Internal Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands
5 Medical Research Council/Clinical Trials Unit, London, UK

* To whom correspondence should be addressed.
Rafaëlla F. A. L'homme, E-mail: R.Lhomme{at}akf.umcn.nl


  Abstract

Objectives: Cipla Pharmaceuticals have developed generic fixed-dose combinations of stavudine, lamivudine and nevirapine for HIV-infected children (Pedimune Baby and Junior). We determined the pharmacokinetic profiles of stavudine, lamivudine and nevirapine in Pedimune and compared these with the branded products.

Methods: This Phase I, comparative, single-centre, open-label, three-period, single-dose study was designed as a pilot study to exclude large differences in pharmacokinetics. Six healthy males were randomized to the following regimen sequences: ABC; ACB; BCA; BAC; CAB; CBA (A = reference, B = Pedimune Baby, C = Pedimune Junior). Single doses of medication were administered at 3 time points 4 weeks apart. An 8 h pharmacokinetic curve was recorded at day 1 of every cycle after medication intake. In addition, blood samples were taken on days 2, 3, 4, 8 and 15.

Results: Non-parametric statistical tests revealed no statistically significant differences in Cmax (0.173 ≤ P ≤ 0.753) and Tmax (0.317 ≤ P ≤ 1.000) of stavudine, lamivudine and nevirapine between the two Pedimune formulations and the branded drugs. Also, there were no significant differences in AUC0-{infty} of stavudine, lamivudine and nevirapine between Pedimune Junior and the branded drugs (0.345 ≤ P ≤ 0.600) and between Pedimune Baby and the branded drug for nevirapine (P = 0.463). In contrast, the AUC0-{infty} of stavudine (mean change: +21%; P = 0.046) and lamivudine (mean change: +14%; P = 0.028) differed significantly between Pedimune Baby and the branded drugs, but these changes were considered not clinically significant.

Conclusions: The pharmacokinetic profiles of stavudine, lamivudine and nevirapine in Pedimune Baby and Junior are comparable to the branded products. Based on these results, it is acceptable to test the pharmacokinetics and dosing requirements of Pedimune in HIV-infected children.

Keywords: stavudine; lamivudine; nevirapine.
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