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Pharmacokinetics/Pharmacodynamics of Desloratadine and Fluoxetine in Healthy Volunteers

From Schering-Plough Research Institute, Kenilworth, New Jersey (Dr Gupta, Dr Banfield, Ms Kantesaria, Mr Flannery), and Arkansas Research Center, Little Rock, Arkansas (Dr Herron).

The authors assessed the potential for a pharmacokinetic/pharmacodynamic interaction between desloratadine and fluoxetine. This randomized, placebo-controlled, open-label study was conducted in 54 healthy volunteers. Subjects received 1 of 3 treatments: desloratadine 5 mg plus fluoxetine 20 mg, desloratadine 5 mg plus placebo, or fluoxetine 20 mg plus placebo. Serial electrocardiograms (ECGs) were performed at baseline and day 35. Treatment effects on C_max and AUC were assessed. During coadministration of desloratadine with fluoxetine, the ratio of the mean log-transformed C_max and AUC values for desloratadine following concomitant fluoxetine therapy revealed a small increase in C_max values of 15% (90% confidence interval [CI], 95%-139%) but no increase for AUC values (90% CI, 82%-123%). Corresponding values for 3-OH desloratadine demonstrated small increases in mean log-transformed C_max and AUC ratios: 17% (90% CI, 100%-136%) and 13% (90% CI, 96%-132%), respectively. Statistical evaluation of the ratio of the mean C_max and AUC values for fluoxetine following concomitant desloratadine therapy revealed small decreases of 9% (90% CI, 72%-115%) and 11% (90% CI, 69%-113%), respectively. Corresponding values for norfluoxetine demonstrated modest increases in mean log-transformed C_max and AUC ratios: 22% (90% CI, 100%-139%) and 18% (90% CI, 101%-136%), respectively. Coadministration of desloratadine with a potent inhibitor of CYP2D6 did not result in clinically relevant changes in its pharmacokinetic parameters. Desloratadine administration was not associated with clinically important changes in the pharmacokinetics of fluoxetine, a drug metabolized by CYP2D6. The most common adverse event in all groups was headache (65%). Desloratadine plus fluoxetine caused no significant changes in ECGs or ventricular rate.

Key Words: Desloratadine • fluoxetine • allergic rhinitis • antihistamines • pharmacokinetics • pharmacodynamics

Address for reprints: Samir K. Gupta, PhD, Schering-Plough Research Institute, K15-22745, 2015 Galloping Hill Road, Kenilworth, NJ 07033.

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