No Pharmacokinetic Interaction Between Lacosamide and Carbamazepine in Healthy Volunteers

¹ SCHWARZ BIOSCIENCES GmbH
² UCB, Inc

^* To whom correspondence should be addressed. E-mail: Willi.Cawello{at}ucb.com.

	Abstract

Lacosamide is a new antiepileptic drug for adjunctive treatment of adult partial-onset seizures. Two open-label, multiple-dose clinical trials were conducted to evaluate the potential for pharmacokinetic interaction between lacos amide and carbamazepine. The influence of carbamazepine on lacosamide pharmacokinetics (trial A) and lacosamide on carbamazepine pharmacokinetics (trial B) was investi gated in 19 (trial A) and 18 (trial B) healthy male partici pants. Trial A participants received lacosamide 200 mg bid alone and with carbamazepine 200 mg bid. Trial B partici pants received carbamazepine 200 mg bid alone and with lacosamide 200 mg bid. Pharmacokinetic parameters, area under the concentration-time curve during a dosage interval at steady state (AUC_,ss), and maximum steady-state plasma drug concentration during a dosage interval (C_max,ss) of lacos amide, carbamazepine, and carbamazepine-10,11-epoxide were measured and compared for each drug alone and together. The AUC_,ss and C_max,ss point estimates (combined vs sole treatment) showed relative bioavailability of approx imately 100% for both drugs. All 90% confidence intervals of AUC_,ss and C_{max, ss} were within the generally accepted bioequivalence ranges of 80% to 125%. No changes in rate or extent of absorption or terminal half-life were observed. These results suggest that lacosamide and carbamazepine have a low potential for pharmacokinetic drug-drug interac tion in clinical use.
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