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First published on June 2, 2008, doi:10.1177/0091270008319792

The Journal of Clinical Pharmacology 2008;48:948.

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©© 2008 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270008319792

Article

Pharmacokinetic Interaction Between Efavirenz and Carbamazepine After Multiple-Dose Administration in Healthy Subjects

Ping Ji 1*, Bharat Damle 2, Jingdong Xie 3, Steve E. Unger 4, Dennis M. Grasela 1, and Sanjeev Kaul 1

1 Bristol-Myers Squibb
2 Pfizer Global Research and Development
3 Forest Research Institute, Forest Laboratories, Inc
4 Discovery Bioanalysis

* To whom correspondence should be addressed. E-mail: ping.ji{at}bms.com.


  Abstract
The effect of efavirenz on the pharmacokinetics of carbamazepine and vice versa was investigated in adult healthy subjects in a randomized, open-label, 2-period crossover, multiple-dose study. Subjects were randomized to receive either efavirenz 600 mg qd for 14 days or carbamazepine titrated to 400 mg qd for 21 days followed with both drugs for another 21 or 14 days. The pharmacokinetics was evaluated for efavirenz, carbamazepine, and the major metabolite of carbamazepine, carbamazepine-10,11-epoxide. Coadministration of carbamazepine with efavirenz significantly reduced the exposure of efavirenz (geometric mean ratios [90% confidence interval]: area of plasma concentration-time curve during the dosing interval of 24 hours [AUC{tau}], 0.64 [0.60-0.68]; maximum plasma concentration [Cmax], 0.79 [0.74, 0.85]) and carbamazepine (AUC{tau}, 0.73 [0.67-0.80]; Cmax, 0.80 [0.76, 0.85]) but had minimal impact on the exposure of carbamazepine-10,11-epoxide (AUC{tau}, 0.99 [0.85-1.15]; Cmax, 1.05 [0.91, 1.22]). In summary, a 2-way pharmacokinetic interaction between efavirenz and carbamazepine was demonstrated in this study.
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M. Zhu, S. Kaul, P. Nandy, D. M. Grasela, and M. Pfister
Model-Based Approach To Characterize Efavirenz Autoinduction and Concurrent Enzyme Induction with Carbamazepine
Antimicrob. Agents Chemother., June 1, 2009; 53(6): 2346 - 2353.
[Abstract] [Full Text] [PDF]


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