This is a phase IIa, multicenter ,randomized, double-blind, placebo-controlled study designed to evaluate the safety, efficacy and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty
This study used a placebo as a control to explore the safety, efficacy and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
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.
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Treatment-Related Adverse Events
By evaluating security metrics such as AEs, SAEs and TEAEs to evaluate the safety of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty.
Time frame: 5 days
The total dose of morphine was administered to the patient 0 to 48 hours after the operation
To evaluate the efficacy of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Time frame: Within 48 hours after the first administration
Peak Plasma Concentration(Cmax)
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Time frame: From 1 hour before the first administration to 48 hours after the last administration.
Minimum concentration (Cmin)
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Time frame: From 1 hour before the first administration to 48 hours after the last administration
Time to peak(Tmax)
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Time frame: From 1 hour before the first administration to 48 hours after the last administration
elimination half life(T1/2)
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
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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.
Time frame: From 1 hour before the first administration to 48 hours after the last administration
Area under the plasma concentration versus time curve (AUC)
To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty
Time frame: From 1 hour before the first administration to 48 hours after the last administration