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Pharmacokinetic Profile of Rizatriptan 10-mg Tablet and 10-mg Orally Disintegrating Tablet Administered With or Without Water in Healthy Subjects: An Open-Label, Randomized, Single-Dose, 3-Period Crossover Study

From DaVita Clinical Research, Minneapolis, Minnesota (Dr Swan, Dr Alcorn); Hennepin County Medical Center, Minneapolis, Minnesota (Dr Swan); and Merck & Co, Inc, West Point, Pennsylvania (Mr Rodgers, Dr Hustad, Ms Ramsey, Ms Woll, and Dr Skobieranda).

This open-label, 3-period crossover study compared the plasma concentration profiles of rizatriptan tablet, orally disintegrating tablet with water (ODTc), and ODT without water (ODTs) in 24 healthy volunteers aged 18 to 45 years. At each period, subjects received a single dose of either 10-mg rizatriptan tablet, 10-mg rizatriptan ODTs, or 10-mg rizatriptan ODTc. The authors hypothesized that ODTc has a greater geometric mean AUC_0-2h than ODTs and that ODTc has a greater geometric mean AUC_0-1h than tablet. A secondary end point was to compare the time of occurrence of the maximum rizatriptan plasma concentration (t_max) of each dosing method. ODTc had a statistically significantly greater geometric mean AUC_0-2h compared with ODTs (33.84 h·ng/mL vs 18.83 h·ng/mL; P < .001). ODTc had a slightly, but not statistically significantly, greater geometric mean AUC_0-1h compared with rizatriptan tablet (17.07 h·ng/mL vs 13.32 h·ng/mL). The median t_max was 0.67 hours for ODTc and tablet and 1.33 hours for ODTs. ODTc showed a slightly, but not significantly, faster rate of absorption compared with tablet. ODTs with water had a faster rate of absorption than ODTc. Future studies are needed to determine whether this pharmacokinetic difference produces differential efficacy in a clinical setting.

Key Words: Rizatriptan • pharmacokinetics • clinical trial • migraine medication

Address for reprints: Franck Skobieranda, MD, Merck & Co, Inc, PO Box 4, HM-323, West Point, PA 19486.

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