NCT07121101

To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Beijing Tide Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Postoperative Analgesia After Unilateral Hip Arthroplasty

Interventions

Type	Name	Description
DRUG	TRD205 tablets	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
DRUG	TRD205 tablets	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.
DRUG	TRD205 tablets	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.
DRUG	placebo	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.

Timeline

• Start date: 2025-09-26
• Primary completion: 2025-11-20
• Completion: 2025-12-27
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: China