Shanghai CureGene Pharmaceutical Co., Ltd.
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.
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…
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.
Orally administered as LD or MD with approximately 240 mL of water.
Orally administered as LD or MD with approximately 240 mL of water.
Arctuva estimate
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