This study is designed to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
Period 1: Dose 1 Tiprogrel, loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
Period 2: Dose 2 Tiprogrel ; loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
Period 3: Clopidogrel; loading dose of Clopidogrel followed by daily maintenance dose until Day 8.
Beijing Tiantan Hosptial, Capital Medical University
Beijing, China
PK parameters: Cmax
Maximum Concentration of Tiprogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PK parameters: Cmax
Maximum Concentration of Clopidogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PK parameters: AUC
Area under the plasma concentration curve of Tiprogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PK parameters: AUC
Area under the plasma concentration curve of Clopidogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PK parameters: Tmax
Time to maximum concentration of Tiprogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PK parameters: Tmax
Time to maximum concentration of Clopidogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PK parameters: T1/2
Half life of Tiprogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PK parameters: T1/2
Half life of Clopidogrel 's active metabolite
Time frame: Day 1 to Day 9 in each period
PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Tiprogrel
ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation
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Period 4: Ticagrelor; loading dose of Ticagrelor followed by daily maintenance dose until Day 8.
Time frame: Day 1 to Day 14 in each period
PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Clopidogrel
ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation
Time frame: Day 1 to Day 14 in each period
PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Ticagrelor
ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation
Time frame: Day 1 to Day 14 in each period
Safety parameters: Number of Participants With Treatment-Related Adverse Events
Time frame: Day 1 to Day 14 in each period