A single-dose, randomized, open-label, two-period crossover bioequivalence study of a fixed-dose pediatric combination of lamivudine 40-mg, nevirapine 70-mg, and stavudine 10-mg tablet for oral suspension with individual liquid formulations in healthy adult male volunteers

Effect of Sorbitol on the Pharmacokinetic Profile of Lamivudine Oral Solution in Adults: An Open‐Label, Randomized Study

“…In contrast with the pediatric findings, an earlier relative bioavailability study in adults demonstrated that lamivudine solution provided equivalent exposures to lamivudine tablets and capsules when both the test and reference formulations were administered alone 5. Additionally, two relative bioavailability studies of pediatric‐strength, three‐drug, fixed‐dose combination tablet formulations that were conducted in children (aged 0.5–12 years) showed that lamivudine solution given in combination with either stavudine/nevirapine or zidovudine/nevirapine liquid formulations had 29% or 44% lower lamivudine exposures than lamivudine administered as part of a three‐drug tablet,6, 7 despite these three‐drug tablet formulations having been shown to be equivalent to solutions in adult relative bioavailability studies 8, 9. Unlike studies in adults, the pediatric relative bioavailability studies were conducted in children being treated for HIV‐1 with lamivudine in combination with one or more antiretroviral drugs.…”

Serum nevirapine and efavirenz concentrations and effect of concomitant rifampicin in HIV infected children on antiretroviral therapy

“…The FDC pediatric formulation of lamivudine, nevirapine, and stavudine is bioequivalent to the individual liquid formulations [25]. Similarly, we found that giving a drug in combination with other anti-retrovirals did not significantly alter the drug levels in the patient's blood, as compared to the drugs being given singly.…”