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 range

18 Years – 50 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PK parameters： Cmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： Cmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： AUC

Timeframe: Day 1 to Day 9 in each period

PK parameters： AUC

Timeframe: Day 1 to Day 9 in each period

PK parameters： Tmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： Tmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： T1/2

Timeframe: Day 1 to Day 9 in each period

PK parameters： T1/2

Timeframe: Day 1 to Day 9 in each period

Trial details

NCT IDNCT06584812

SponsorTianjin Institute of Pharmaceutical Research Co., Ltd

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-12-05

View on ClinicalTrials.gov More Acute Coronary Syndrome trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

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

What they're measuring

PK parameters： Cmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： Cmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： AUC

Timeframe: Day 1 to Day 9 in each period

PK parameters： AUC

Timeframe: Day 1 to Day 9 in each period

PK parameters： Tmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： Tmax

Timeframe: Day 1 to Day 9 in each period

PK parameters： T1/2

Timeframe: Day 1 to Day 9 in each period

PK parameters： T1/2

Timeframe: Day 1 to Day 9 in each period