NCT03942458

Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, randomized, open, two-cycle crossover, clopidogrel control, multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior of different metabolites of CYP2C19 in healthy subjects. The study enrolled 48 patients, divided into three groups of CYP2C19 fast metabolite, middle metabolite, and slow metabolism, 16 cases in each group. All groups of subjects were administered for 7 days in the first cycle, once a day (loading dose on the first day, maintenance dose on other days), and entering the 14-day washout period after the end of the first cycle. The second cycle was entered, and the second cycle was administered for 7 days, once a day (the first day was given a loading dose, and the other days were given a maintenance dose). Blood was collected before and after administration of D1, D7, D22, and D28, and PK/PD was measured.

Conditions

• Healthy Subjects
• PK/PD

Interventions

Type	Name	Description
DRUG	Vicagrel 6mg	Vicagrel 24mg loading followed by 6mg/day for 6 days
DRUG	Clopidogrel 75mg	Clopidogrel 300mg loading followed by 75mg/day for 6 days

Timeline

• Start date: 2019-04-03
• Primary completion: 2019-06-28
• Completion: 2019-09-03
• First posted: 2019-05-08
• Last updated: 2019-09-19

Locations

1 site across 1 country: China