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Aims  Levodopa‐carbidopa intestinal gel ( LCIG ) provides continuous levodopa‐carbidopa delivery through intrajejunal infusion. This study characterized the population pharmacokinetics of levodopa following a 16 h jejunal infusion of  LCIG  or frequent oral administration of levodopa‐carbidopa tablets ( LC ‐oral) in subjects with advanced  P arkinson's disease ( PD ).    Methods  A non‐linear mixed‐effects model of levodopa pharmacokinetics was developed using serial plasma concentrations from an  LCIG  phase 1 study and a phase 3 double‐blind, double‐dummy study of the efficacy and safety of  LCIG  compared with  LC ‐oral in advanced  PD  patients ( n  = 68 for model development; 45 on  LCIG  and 23 on  LC ‐oral). The final model was internally evaluated using stochastic simulations and bootstrap and externally evaluated using sparse pharmacokinetic data from 311 subjects treated in a long term safety study of  LCIG .    Results  The final model was a two compartment model with a transit compartment for absorption, first order elimination, bioavailability for  LCIG  (97%; confidence interval = 95% to 98%) relative to  LC ‐oral, different first order transit absorption rate constants ( LCIG  = 9.2 h –1   vs .  LC ‐oral = 2.4 h –1 ; corresponding mean absorption time of 7 min for  LCIG   vs.  25 min for  LC ‐oral) and different residual (intra‐subject) variability for  LCIG  (15% proportional error, 0.3 μg ml −1  additive error)  vs.   LC ‐oral (29% proportional error, 0.59 μg ml −1  additive error). Estimated oral clearance and steady‐state volume of distribution for levodopa were 24.8 l h −1  and 131 l, respectively.    Conclusions   LCIG  administration results in faster absorption, comparable levodopa bioavailability and significantly reduced intra‐subject variability in levodopa concentrations relative to  LC ‐oral administration.

Population pharmacokinetics of levodopa in subjects with advanced P arkinson's disease: levodopa‐carbidopa intestinal gel infusion vs . oral tablets