Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model

ConclusionsA one-compartment model parameterized in terms ofF, absorption rate constant,CL/F, andV/F described the data well. The model demonstrated that plasma tadalafil concentrations in pediatric patients aged 2 to< 18 years were similar to those in adults at similar doses, and confirmed that dosing of 40 mg once daily in pediatric patients with a bodyweight ≥ 40 kg, and a dose of 20 mg once daily in patients with a body weight< 40 kg and aged ≥ 2 years are suitable for phase III evaluation.Trial Registration Number (Date of Registration)LVIG: ClinicalTrials.gov identifier: NCT01484431 (2 December 2011). PHIRST-1: ClinicalTrials.gov identifier: NCT00125918 (2 August 2005).

http://link.springer.com/10.1007/s40262-021-01052-8

Source: Clinical Pharmacokinetics - August 11, 2021 Category: Drugs & Pharmacology Source Type: research