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• W2979154545 abstract "Purpose: To characterize the pharmacokinetic (PK) and safety profile of single and repeated doses of pantoprazole granules and tablets in children aged 1–11 yr with endoscopically proven GERD. Methods: This was a multicenter, randomized, open-label study of 2 dose levels of pantoprazole (0.6 mg/kg and 1.2 mg/kg) administered once daily as granules or tablets to children aged 1–11 yr weighing ≥8.3 kg to < 25 kg. Patients were stratified by age group (1 through < 2 yr, 2 through < 6 yr, 6 through < 12 yr). For patients aged 1 through < 6 yr, dose strength was based on weight: 5 or 15 mg pantoprazole granules for patients who were ≥8.3 to ≤12.5 kg and 10 or 20 mg for those > 12.5 kg to < 25 kg. Patients aged 6 through < 12 yr received 20 or 40 mg tablets. Plasma concentrations were determined by HPLC/MS/MS from samples obtained pre-dose and 0.5, 1, 2, 4, 6 and 12 hr post dose on study day 1, and at 2 and 4 hr post dose on day 7 ± 2. Concentration-time data were analyzed with non-compartmental methods. PK parameters, summarized by formulation for each dose group, included peak concentration (Cmax), time to Cmax (tmax), half-life (t1/2), area under the concentration-time curve (AUC), and apparent clearance (Cl/F). Routine safety was evaluated. Genotyping was done for CYP2C19 and CYP3A4. Results: 41 patients were enrolled, 17 aged 1–5 yr (granules) and 24 aged 6–11 yr. The mean age was 6.4 yr with 61% males and 83% Caucasians. All patients had a CYP2C19 genotype predictive of an extensive metabolizer type. Eight patients were heterozygous for CYP2C19*1/*2 and 7 for CYP3A4*1/*B, and 1 was homozygous for CYP3A4*B/*B. Pantoprazole was absorbed more rapidly for the tablet compared with the granules formulation. Cmax and AUC values increased with increasing dose. Plasma concentrations after single dose administration were below or close to LLQ at 12 hr post dose, and there was no evidence of drug accumulation after multiple doses (data not shown). Wide variability in the absorption of pantoprazole was observed. There were no serious AEs or withdrawals due to AEs. Conclusion: Pantoprazole granules or tablets were safe and well tolerated in patients aged 1 through 11 yr with endoscopically proven GERD. Exposure observed with the 1.2 mg/kg dose (40 mg) in children aged 6 to 11 years was similar to that observed in adults with a 40 mg dose.Table" @default.
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• W2979154545 date "2008-09-01" @default.
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• W2979154545 title "Pharmacokinetics of Two Dose Levels of Pantoprazole Sodium Granules and Tablets in Children Aged 1 Through 11 Years with Endoscopically Proven GERD" @default.
• W2979154545 doi "https://doi.org/10.14309/00000434-200809001-01348" @default.
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