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 .
This study used a placebo as a control to explore the safety, efficacy and pharmacokinetic characteristics of multiple administration of TRD205 tablets at different doses for postoperative analgesia after unilateral hallux valgus correction surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Administered 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.
Administered 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.
Administered 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.
Beijing Jishuitan Hosapital
Beijing, Beijing Municipality, China
Treatment-Related Adverse Events
Assessment of all AEs, SAEs and TEAEs
Time frame: 5 Days
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.
Time frame: Within 48 hours after the first administration
Peak Plasma Concentration(Cmax)
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Time frame: 5 days
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 frame: 5 days
time to peak(Tmax)
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Time frame: 5 days
elimination half life(T1/2)
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Time frame: 5 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered 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.