Pharmacokinetic Study of Frovatriptan Succinate Tablet After Single and Multiple Oral Doses in Chinese Healthy Subjects

Abstract

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 multiple-dose 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.

Keywords:

• frovatriptan succinate
• pharmacokinetics
• single-dose
• multiple-dose

Data Sharing Statement

The individual participant’s data that underlying the results reported in this article would be accessed with approval from the corresponding author after 6 months of publication. The study protocol, statistical analysis plan and clinical study report will also be available.

Disclosure

There is no competing interests among the authors.

Additional information

Funding

This study was sponsored by CP Pharmaceutical Qingdao Co., Ltd., Qingdao, Shandong, China.