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NOT YET RECRUITING
NCT07121101
PHASE2

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

Sponsor: Beijing Tide Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-26

Completion Date

2025-12-27

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China