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- W1567377593 abstract "OBJECTIVE: Assess the bioequivalence of oral to intravenous (IV) carbamazepine (CBZ) infused at 75[percnt] and 80[percnt] of the oral total daily dose (TDD) every 6 hours (q6h) using a pharmacokinetic (PK) model. BACKGROUND: Patients may be unable to take oral CBZ due to illness or surgery. Results from a clinical study showed IV CBZ infused at 70[percnt] of TDD q6h was bioequivalent to oral CBZ. DESIGN/METHODS: CBZ plasma concentration profiles and PK parameters were simulated for oral and IV CBZ infused for 15- or 30-minutes q6h at 75[percnt] or 80[percnt] of the oral TDD. Minimum, maximum, and average plasma concentrations (C min , C max , and C avg , respectively), area under the time-concentration curve from 0-24 hours (AUC 0-24 ), and partial 2 hour AUCs were determined. Bioequivalence between oral and IV CBZ was declared if the 90[percnt] confidence intervals (CIs) of the ratio of geometric LSMs for the PK parameters were between 80-125[percnt]. RESULTS: Simulated and observed values of IV CBZ infused over 15 minutes q6h at 70[percnt] of the oral TDD were similar and validated the model. Predicted steady-state estimates of C min and C avg were within the 90[percnt] CIs for the 15 minute infusion rate; predicted C max was above the upper CI limit for both dose conversions. For 15-minute IV CBZ infusions, most predicted steady-state estimates of Cmin and Cavg were within and predicted Cmax values above the CI limit at 75[percnt] and 80[percnt] of the oral TDD. Partial AUC predictions for IV CBZ 15-minute infusions appeared to be better than the 30-minute infusions. CONCLUSIONS: PK simulations showed that the IV CBZ 15-minute infusion rate q6h at 75[percnt] and 80[percnt] of the oral TDD were bioequivalent to oral CBZ for C min , C avg , and AUC 0-24 . IV CBZ infused over 15 minutes q6h appeared to better meet the 90[percnt] CI criteria for bioequivalence. Support: Lundbeck LLC Disclosure: Dr. Tolbert has received personal compensation for activities with Lundbeck Research USA, Inc. as an employee. Dr. Ravis has received personal compensation for activities with Lundbeck Research USA, Inc. as a consultant. Dr. Karim has received personal compensation for activities with Lundbeck Research USA, Inc. as an employee." @default.
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- W1567377593 date "2015-04-06" @default.
- W1567377593 modified "2023-09-23" @default.
- W1567377593 title "Pharmacokinetic Evaluations of Oral and Intravenous Carbamazepine using a Model-Based Approach (P4.257)" @default.
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