NCT06584812

Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects

A Phase I Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety in Healthy Subjects with Multiple Administration of Tiprogrel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Tianjin Institute of Pharmaceutical Research Co., Ltd · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel.

Detailed description

Tiprogrel is a novel oral P2Y12 receptor antagonist.This study is to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel, and compare pharmacokinetics /pharmacodynamic of Tiprogrel,Clopidogrel and Ticagrelor.

Conditions

• Acute Coronary Syndrome
• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tiprogrel	Period 1: Dose 1 Tiprogrel, loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
DRUG	Tiprogrel	Period 2: Dose 2 Tiprogrel ; loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
DRUG	Clopidogrel	Period 3: Clopidogrel; loading dose of Clopidogrel followed by daily maintenance dose until Day 8.
DRUG	Ticagrelor	Period 4: Ticagrelor; loading dose of Ticagrelor followed by daily maintenance dose until Day 8.

Timeline

• Start date: 2024-09-09
• Primary completion: 2024-12-05
• Completion: 2024-12-17
• First posted: 2024-09-05
• Last updated: 2025-01-06

Locations

1 site across 1 country: China