Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects (NCT06584812) | Clinical Trial Compass
CompletedPhase 1
Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects
China14 participantsStarted 2024-09-09
Plain-language summary
This study is designed to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female Healthy Subjects
✓. Subject has the ability and willingness to comply with study procedures and follow-up examination.
Exclusion criteria
✕. History or presence of metabolic, allergy, dermatology, liver, kidney, hematology, cardiovascular, gastrointestinal, nervous, respiratory, endocrine or psychiatric diseases.
✕. History or presence of obviously active bleeding, or coagulation or bleeding disorders, or any skin petechiae, or thrombus, or spontaneous bleeding.
✕. Subject with history of allergy to a variety of drugs, or has a known or suspected hypersensitivity to tiprogrel or other anti-platelet drugs
✕. Subjects who had a history of major surgery within 3 months before the trial or planned to undergo surgery during the study period.
✕. Subjects who have lost or donated ≥ 400 mL blood or received blood transfusion or used blood products within three months, or subjects with clinically significant anemia based on the judgment of the Investigator
✕. Subjects with systolic blood pressure of \> 140 mmHg or \< 90 mmHg, diastolic blood pressure of \> 90 mmHg or \< 60 mmHg
✕. Subjects with 12-lead ECG examination: QTcF \> 450 msec
✕. Platelet count (PLT) value, beyond the laboratory's reference range
What they're measuring
1
PK parameters： Cmax
Timeframe: Day 1 to Day 9 in each period
2
PK parameters： Cmax
Timeframe: Day 1 to Day 9 in each period
3
PK parameters： AUC
Timeframe: Day 1 to Day 9 in each period
4
PK parameters： AUC
Timeframe: Day 1 to Day 9 in each period
5
PK parameters： Tmax
Timeframe: Day 1 to Day 9 in each period
6
PK parameters： Tmax
Timeframe: Day 1 to Day 9 in each period
7
PK parameters： T1/2
Timeframe: Day 1 to Day 9 in each period
8
PK parameters： T1/2
Timeframe: Day 1 to Day 9 in each period
9
PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Tiprogrel
Trial details
NCT IDNCT06584812
SponsorTianjin Institute of Pharmaceutical Research Co., Ltd