Comparison of pharmacokinetics of citalopram in healthy Asian Indian and Mexican volunteers

Tomar, Manoj Singh; Patni, Anil; Iyer, Sunil S.; Khuroo, Arshad; Kumar, Sanjeev; Thudi, Nageshwar Rao; Jain, Rakesh K.; Rana, Sachin; Monif, Tausif

doi:10.3109/10601333.2010.546799

Cited by 2 publications

(3 citation statements)

References 15 publications

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“…(F) Validation plot with a single dose of a 40‐mg citalopram tablet, as observed by Gutierrez et al . (G) Validation plot with a single dose of a 20‐mg citalopram tablet using a white population to simulate a Mexican population, as observed by Tomar et al . (H) Validation plot with a single dose of a 20‐mg citalopram tablet, as observed by Spigset et al .…”

Section: Resultsmentioning

confidence: 76%

“…Three published studies in humans were not included, as limited concentration-time profiles or only trough levels were provided. 8,27,28 Detailed information of all available studies, 6,7,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43] including those used for model development and verification, is included in Supplemental Tables 1-4.…”

Section: Clinical Pharmacokinetic Studiesmentioning

confidence: 99%

“…Percentage errors of C max , AUC, and T max were within −30% and +30% for all validations, with 3 exceptions for AUC and T max (Figure 2). Simulated PK profiles of test formulations in Tomar et al 42 are not shown here because they had similar PK profiles and PK parameters and were bioequivalent to the reference product. Figure 4 shows the model validation plots after multidose oral administration of citalopram.…”

Section: Citalopram Exposure Prediction After Intravenous Infusionmentioning

confidence: 99%

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Physiologically Based Pharmacokinetic Approach Can Successfully Predict Pharmacokinetics of Citalopram in Different Patient Populations

Zhang

Miah

et al. 2019

The Journal of Clinical Pharma

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A physiologically based pharmacokinetic model (PBPK) was built for citalopram using Simcyp‐based absorption, distribution, metabolism, and excretion simulator. Various physicochemical properties of citalopram were obtained from the published literature. The in vitro‐in vivo extrapolation method was used to predict clearance in humans from recombinant enzyme data. Tissue distribution was predicted using parameter estimation function to fit the developed model to the observed concentration‐versus‐time data using nonlinear mixed‐effects modeling approach. The model was verified by comparing the PBPK‐based predictions with the observed pharmacokinetic (PK) profiles of citalopram in 26 clinical studies across a dose range of 10 to 60 mg. The predicted PK parameters of citalopram after intravenous dosing were within the −10% to 22% of the corresponding PK parameters obtained from the studies with quantified data sets. Most of the predicted PK parameters of citalopram after single‐dose oral administration were within the 70%‐130% range of the corresponding PK parameters obtained from observed data from 8 studies. After multidose oral administration, percentage error of Cmax and AUC was between −21% and 25% and −31% and 21%, respectively. Most of the observed data were within the 5th and 95th percentile interval of the variability around the predicted plasma concentrations. With the established model, the PK profiles in geriatric populations, populations with cytochrome P450 (CYP) 2C19 and/or 2D6 extensive metabolizers or poor metabolizers were predicted, and the predictions were in good agreement with the observed data. The model developed is robust to represent the absorption and disposition of citalopram and can predict the impact of patient covariates, such as age and genetic polymorphism of CYP2C19 and CYP2D6, on exposure of citalopram.

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Section: Resultsmentioning

confidence: 76%

Section: Clinical Pharmacokinetic Studiesmentioning

confidence: 99%

Section: Citalopram Exposure Prediction After Intravenous Infusionmentioning

confidence: 99%

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Physiologically Based Pharmacokinetic Approach Can Successfully Predict Pharmacokinetics of Citalopram in Different Patient Populations

Zhang

Miah

et al. 2019

The Journal of Clinical Pharma

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Oral Ciprofloxacin Pharmacokinetics in Healthy Mexican Volunteers and Other Populations: Is There Interethnic Variability?

Tolentino-Hernández

Cruz-Antonio

Pèrez‐Urizar

et al. 2020

Archives of Medical Research

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Comparison of pharmacokinetics of citalopram in healthy Asian Indian and Mexican volunteers

Cited by 2 publications

References 15 publications

Physiologically Based Pharmacokinetic Approach Can Successfully Predict Pharmacokinetics of Citalopram in Different Patient Populations

Physiologically Based Pharmacokinetic Approach Can Successfully Predict Pharmacokinetics of Citalopram in Different Patient Populations

Oral Ciprofloxacin Pharmacokinetics in Healthy Mexican Volunteers and Other Populations: Is There Interethnic Variability?

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