This is a multicenter, randomized, double-blind, placebo-controlled phase Ib study designed to evaluate the safety, efficacy and PK of TRD205 tablets administered orally .
Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent form, and voluntarily comply with the trial procedures;
18 to 75 years of age, male or female;
18 kg/m 2 ≤ BMI ≤ 30 kg/m 2 , Include Cut-off value ;
American Society of Anesthesiologists (ASA) physical status I to II (Appendix) 6 );
Known allergies or contraindications to the investigational drug and other drugs that may be used during the trial, and those who are not suitable for participating in the trial judged by the investigator;
Before randomization 5 half-lives The following drugs (subject to the actual package insert, with half-life unknown, then washout at 48h) are used internally, including but not limited to: analgesic drugs (except those specified in the protocol), anticonvulsants, sedative and hypnotic drugs (except those specified in the protocol), anxiolytics, antidepressants, CYP3A4 enzyme inhibitors or inducers, etc. See the List of Prohibited Drugs for the specific types;
Random First 7 days Inner Use of Chinese herbal medicine with clear analgesic effect as assessed by the investigator;
Patients who cannot take oral drugs after surgery as judged by the investigator ;
Parallel
TRD205 tablets
DrugAdministered orally every 12 hours for a total of four times；Take TRD205 2 tablets and Placebo 4 tablets for the first time ，TRD205 1 tablets and Placebo 2 tablets each for the other three times.
TRD205 tablets
DrugAdministered orally every 12 hours for a total of four times；Take TRD205 4 tablets and Placebo 2 tablets for the first time ，TRD205 2 tablets and Placebo 1 tablets each for the other three times.
TRD205 tablets
DrugAdministered orally every 12 hours for a total of four times；Take TRD205 6 tablets and Placebo 0 tablets for the first time ，TRD205 3 tablets and Placebo 0 tablets each for the other three times.
Placebo
DrugAdministered orally every 12 hours for a total of four times；Take Placebo 6 tablets for the first time ，Placebo 3 tablets each for the other three times.
Treatment-Related Adverse Events
Assessment of all AEs, SAEs and TEAEs
Sum of Pain Intensity Differences from hour 0 to hour 48 (SPID48).Resting state in a resting state
Pain intensity (PI) was assessed using the 11-point numeric pain rating scale (0-10; 0 equated to no pain, and 10 equated to the worst pain imaginable) at predose and at15min、30min、45min、1h、1.5h、2h、2.5h、3h、4h、5h、6h and 8 h, and then at 4-hour intervals until hour 48.
Peak Plasma Concentration（Cmax）
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Area under the plasma concentration versus time curve （AUC）
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
time to peak（Tmax）
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
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Beijing Tide Pharmaceutical Co., Ltd
Lead sponsor
Beijing Jishuitan Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
