Population Pharmacokinetics of Clindamycin Hydrochloride Capsules in
Chinese health subjects
Abstract
Aim: The aim of the research is to establish a population
pharmacokinetic (PPK) model of Clindamycin hydrochloride capsules in
Chinese health subjects and investigate the factors affecting the
pharmacokinetic parameters to provide guidance for the individualized
treatment of Clindamycin. Methods: Clindamycin concentrations were
measured in 48 selective health subjects (30 males and 18 females aged
18-45 years). The subjects were assigned to two groups randomly. 150mg
Clindamycin oral administration were given at fasting or postprandial,
respectively. Blood samples were collected at specified time. A total of
1344 blood drug concentration data were analyzed using NONMEM. The
Non-linear mixed effect model was conducted to establish the population
pharmacokinetic model of Clindamycin in Chinese healthy patients. The
model was verified and evaluated by Visual Prediction Test (VPC) and
Bootstrap method. Results: This study established a one-compartment
pharmacokinetic model of Clindamycin hydrochloride capsules in Chinese
healthy subjects. The final population pharmacokinetic parameters were
oral absorption coefficient (Ka=2.69 h-1), apparent volume of
distribution (V/F=76.74 L) and apparent clearance (CL/F= 30.10 L·h-1).
And the food was the only significant covariate in the model. The final
model was stable and predictable, verified by VPC and Bootstrap.
Conclusion: A robust and predictable population pharmacokinetic model of
Clindamycin in Chinese healthy subjects was constructed successfully.
The dietary state had a significant effect on the pharmacokinetics of
Clindamycin which gave an important steer for dose adjustment or
changing medication in clinical practice. Moreover, the model had great
potential to guide the individualized medication of Clindamycin.