A pharmacokinetic comparison of adult and paediatric formulations of raltegravir in healthy adults.

Background: RAL is a HIV-1 integrase strand transfer inhibitor approved for treatment of HIV-1 in combination with other antiretrovirals in adults. Infection is not limited to adults, thus pediatric development of this compound is warranted and underway. Two pediatric formulations have been developed: the chewable ethylcellulose (EC) formulation and an oral granule (OG) formulation for suspension. The current study evaluated the safety and tolerability of these pediatric formulations and compared their plasma pharmacokinetic profiles after single doses of 400 mg to that obtained after a single dose of the marketed poloxamer (POL) tablet formulation. In addition, the effect of a high-fat meal on the pharmacokinetics of the EC formulation was assessed.