Abstract
Objective: To compare a new formulation, Paracetamol Pediatric Suspension (PPS), designed to reach therapeutic levels rapidly, to marketed formulations of Children's PanadolĀ® (CP) and PanodilĀ® Baby & Infant Suspensions (PBIS) The trial measured the rate and extent of absorption and bioequivalence in fasted and semifed states of the three paracetamol formulations.
Methods: A pivotal, single-center, open-label, sixway crossover pharmacokinetic (PK) study, in 28 healthy, male, adult-volunteers These subjects received a single oral dose of 10g paracetamol in three randomized treatments in fasted and semifed states with a 24-hour washout period between doses during a 7-day/6-night residential period at the study site.
Results: Regression analyses of AUC010hrs, AUC0-inf, and Cmax confirmed that the three formulations were bioequivalent in the fasted and semi-fed states, with 90% confidence intervals (080-125) In the semi-fed state, PPS had a significantly higher early exposure (AUC030min and AUC0-60min, all P-values< 005), and Tmax was shorter (by 30 minutes; P< 00001) compared with PBIS Food increased early PPS absorption significantly, while decreasing total absorption (AUC0-inf and AUC010hrs) Time to reach therapeutic level (4 mg/ml) was significantly shorter for PPS than comparators In the first 10 minutes after semi-fed dosing, 50% of subjects treated with PPS, 32% with CP and 7% with PBIS reached therapeutic level.
Conclusions: In fasted and semi-fed states, PPS is bioequivalent and showed some superior PK parameters of early absorption for 4 hours to CP and PBIS PPS is safe and well-tolerated with no adverse events.
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Smith, S., Colgan, B., McLaverty, D. et al. 687 Pharmacokinetic Study (A2210378) Comparing Two Pediatric Paracetamol Suspensions Shows Bioequivalence, and Faster Early Absorption of New Formulation. Pediatr Res 68 (Suppl 1), 349ā350 (2010). https://doi.org/10.1203/00006450-201011001-00687
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DOI: https://doi.org/10.1203/00006450-201011001-00687