Purpose: The present report describes findings from a Phase I clinical study that evaluated the single-and multiple-dose pharmacokinetics of frovatriptan succinate tablet in Chinese healthy subjects. Methods: A total of 24 healthy subjects were enrolled. In single-dose study, 2.5, 5, and 10 mg oral doses of frovatriptan succinate tablet were administrated. A 2.5 mg frovatriptan succinate tablet was administrated 12 times in 7 days in the multiple-dose study. Blood samples were collected at scheduled time points. Results:The results in single-dose study indicated that the blood levels were proportional to the administered dose, with the mean C max and AUC last ranging from approximately 6.27 ng/ mL-17.35 ng/mL and 92.52 h•ng/mL -287.40 h•ng/mL over the dose range. In the multipledose study, moderate drug accumulation was noted, which was attributable to forvatriptan's long t 1/2 of about 26.47 to 30.63 h. Gender differences were noticed in both single-and multiple-dose study; exposure PK parameters were consistently higher in female than in male. Conclusion: These pharmacokinetic evaluations in healthy Chinese subjects found that frovatriptan succinate tablet has an acceptable pharmacokinetic profile in Chinese subjects.
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