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RECRUITING
NCT07619885
PHASE1

The Pharmacokinetics and Pharmacodynamics Study of CG-0255 Besylate and Plavix® in Healthy Participants

Sponsor: Shanghai CureGene Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

CG-0255 is a novel investigational prodrug of the active metabolite of Plavix®, but with different active metabolite conversion routes. This is a randomized, open-label and Plavix®-controlled study to compare the PK and PD of CG-0255 Besylate and Plavix® in healthy participants.

Official title: A Pivotal Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of CG-0255 Besylate and Plavix® in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2026-06

Completion Date

2026-12

Last Updated

2026-06-05

Healthy Volunteers

Yes

Interventions

DRUG

CG-0255 Besylate for Injection

Calculate the dosage and number of vials required for a participant according to body weight. Reconstitute with 5 mL of sterile water for each 5 mg/vial to get clear solution for injection in 1 mg/mL (as CG-0255). The reconstituted CG-0255 Besylate for injection (1 mg/mL), must be further diluted in 100 mL normal saline infusion bag, following the instruction in the pharmacy manual.

DRUG

CG-0255 Besylate Capsule

Orally administered as LD or MD with approximately 240 mL of water.

DRUG

Clopidogrel

Orally administered as LD or MD with approximately 240 mL of water.

Locations (1)

Syneos Health

Miami, Florida, United States