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Effect of Carisbamate on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Participants

Effect of Carisbamate on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Participants

Martha Gonzalez, Peter Zannikos, Allitia DiBernardo, H Robert Brashear, Jay Ariyawansa

J Clin Pharmacol. 2012 Sep;52(9):1420-9.

PMID: 22011511

Abstract:

Carisbamate's effect (200 mg twice-daily [study 1], 600 mg twice-daily [study 2]) on warfarin's (25 mg single dose) pharmacokinetics and pharmacodynamics (international normalized ratio) was assessed during 2 open-label studies in healthy participants. Coadministration of either carisbamate regimen produced small changes on the mean maximum plasma concentration (C(max)) and mean area under the plasma concentration-time curve to the last measurable time point (AUC(last)) of (S)- and (R)-warfarin, which are unlikely to be clinically significant. For (S)-warfarin, the ratios (with carisbamate/without carisbamate) of geometric means for C(max) were 105.44 (study 1) and 98.48 (study 2) and for AUC(last) were 109.33 (study 1) and 114.43 (study 2); the corresponding 90% confidence intervals were within the bioequivalence limits of 80% to 125%. Results were similar for (R)-warfarin. Carisbamate at 600 mg (but not 200 mg) twice-daily prolonged the elimination half-life of (S)- and (R)-warfarin by ~10 hours (25% and 32% increase, respectively). Prothrombin time was unaltered by either carisbamate dose. Adverse events with the highest incidence were dizziness (50%) and headache (50%) in study 1 and somnolence (56%) in study 2. Warfarin exposure and international normalized ratio were unaffected by coadministration of carisbamate 200 mg or 600 mg twice-daily. Carisbamate was well tolerated.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP194085751	Carisbamate		194085-75-1	Price

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