scholarly journals Population pharmacokinetics of deferiprone in healthy subjects

2014 ◽  
Vol 78 (6) ◽  
pp. 1397-1406 ◽  
Author(s):  
Francesco Bellanti ◽  
Meindert Danhof ◽  
Oscar Della Pasqua
Keyword(s):  
Population Pharmacokinetics ◽  
Healthy Subjects

Population pharmacokinetics of the rilpivirine long-acting formulation after intramuscular dosing in healthy subjects and people living with HIV

2021 ◽  
Author(s):  
M Neyens ◽  
H M Crauwels ◽  
J J Perez-Ruixo ◽  
S Rossenu
Keyword(s):  
Population Pharmacokinetics ◽  
Healthy Subjects ◽  
Phase Iii ◽  
Intramuscular Administration ◽  
Population Pharmacokinetic ◽  
People Living With Hiv ◽  
Concentration Data ◽  
Flip Flop ◽  
Long Acting ◽  
Living With Hiv

Abstract Objectives To characterize the population pharmacokinetics of the rilpivirine long-acting (LA) formulation after intramuscular administration. Methods Rich and sparse rilpivirine plasma concentration data were obtained from seven clinical studies. In total, 18 261 rilpivirine samples were collected from 986 subjects (131 healthy subjects from Phase I studies and 855 people living with HIV from Phase IIb/III studies). Doses ranged from 300 to 1200 mg, as single-dose or multiple-dose regimens (every 4 or 8 weeks). In Phase III studies, an initiation injection of 900 mg followed by continuation injections of 600 mg every 4 weeks was used. Non-linear mixed-effects modelling was performed using NONMEM® software. Results A one-compartment model with linear elimination and two parallel absorption pathways (fast and slow) with sequential zero-first-order processes adequately captured rilpivirine flip-flop pharmacokinetics after intramuscular administration of the LA formulation. The estimated apparent elimination half-life of rilpivirine LA was 200 days. None of the evaluated covariates (age, body weight, BMI, sex, race, health status and needle length) had a clinically relevant impact on rilpivirine pharmacokinetics. Conclusions The population pharmacokinetic model suitably describes the time course and associated variability of rilpivirine plasma concentrations after rilpivirine LA intramuscular administration. The monthly regimen consists of an oral lead-in period (rilpivirine 25 mg tablets once daily for 4 weeks), followed by an initiation injection of 900 mg rilpivirine LA, then 600 mg rilpivirine LA continuation injections monthly. The absence of a clinically relevant effect of covariates on rilpivirine pharmacokinetics suggests that rilpivirine LA dose adjustments for specific subgroups are not warranted.

Population Pharmacokinetics of Tapentadol Immediate Release (IR) in Healthy Subjects and Patients with Moderate or Severe Pain

2010 ◽  
Vol 49 (10) ◽  
pp. 671-682 ◽  
Author(s):  
Xu Steven Xu ◽  
Johan W. Smit ◽  
Rachel Lin ◽  
Kim Stuyckens ◽  
Rolf Terlinden ◽  
...  
Keyword(s):  
Population Pharmacokinetics ◽  
Healthy Subjects ◽  
Severe Pain ◽  
Immediate Release

Population Pharmacokinetics of Onercept in Healthy Subjects

2005 ◽  
Vol 44 (12) ◽  
pp. 1295-1304 ◽  
Author(s):  
Sophie Glatt ◽  
Eliane Fuseau ◽  
Mauro Buraglio ◽  
Quyen T X Nguyen
Keyword(s):  
Population Pharmacokinetics ◽  
Healthy Subjects
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