A Pivotal Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of CG-0255 Besylate and Plavix® in Healthy Participants
Shanghai CureGene Pharmaceutical Co., Ltd.
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants must be fully informed about the study, willing to participate, and sign the informed consent document prior to any procedure. * Healthy male and female participants, aged 18 to 55 years (inclusive) at time of signing informed consent form. * Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) at screening and body weight between 45 and 120 kg (inclusive). * Smoking \< 10 cigarettes (10-20 mg of nicotine/month) or equivalent amount of nicotine products per month within 6 months prior to screening and agree to abstain from tobacco and/or nicotine produc…
Interventions
- DrugCG-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.
- DrugCG-0255 Besylate Capsule
Orally administered as LD or MD with approximately 240 mL of water.
- DrugClopidogrel
Orally administered as LD or MD with approximately 240 mL of water.
Location
- Syneos HealthMiami, Florida