DDMODEL00000323: Population pharmacokinetic plasma model of chloroquine in healthy volunteers

Short description:
Population pharmacokinetic properties of chloroquine in healthy volunteers, following a single oral dose (620 mg base) given either alone or in combination with primaquine.
Original code |
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Richard Hoglund
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Context of model development: | Variability sources in PK and PD (CYP, Renal, Biomarkers); |
Long technical model description: | Chloroquine plasma data is described by a three-compartment disposition model with three transit compartments describing the absorption phase. The model included relative bioavailability fixed to 100%. Between-occasion variability were added on MTT and elimination data under the limit of quantification were handled with the M6 method. Concomitant treatment with primaquine did not have any effect on the pharmacokinetic properties of chloroquine; |
Model implementation requiring submitter’s additional knowledge: | No; |
Modelling context description: | The model is based on plasma data from a two-arm crossover, three-period, randomised clinical trial investigating the drug-drug interactions between chloroquine and primaquine. A total of 16 healthy volunteers participated in the study. Participants received single doses of chloroquine either alone or together with primaquine. Plasma samples were collected and analysed for chloroquine concentration. The measured concentrations were modelled using NONMEM; |
Modelling task in scope: | estimation; |
Nature of research: | Clinical research & Therapeutic use; |
Therapeutic/disease area: | Anti-infectives; |
Annotations are correct. |
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This model is not certified. |