This is a phase IIa, multicenter ,randomized, double-blind, Double-Dummy, Active- and placebo-controlled study designed to evaluate the efficacy, safety and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty
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Eligibility Criteria
Inclusion Criteria:
* Able to provide written informed consent
* Age 18 to 80 years, inclusive
* BMI 18-32 kg/m²
* ASA physical status I-II
* Scheduled for elective unilateral total hip arthroplasty under general anesthesia
* Able to understand study procedures and pain rating scales
Exclusion Cri…
Inclusion Criteria:
* Able to provide written informed consent
* Age 18 to 80 years, inclusive
* BMI 18-32 kg/m²
* ASA physical status I-II
* Scheduled for elective unilateral total hip arthroplasty under general anesthesia
* Able to understand study procedures and pain rating scales
Exclusion Criteria:
* Hypersensitivity to TRD205, celecoxib, or study-related medications
* Use of prohibited analgesics, sedatives, CYP3A4 inhibitors/inducers, or analgesic herbs within specified washout periods
* Inability to take oral medications postoperatively
* Ipsilateral hip surgery within 1 year; contralateral hip surgery within 1 month
* Hip revision surgery, developmental dysplasia Crowe type IV, or tumor involving hip
* Clinically significant hemodynamic instability or cardiac arrhythmia
* Severe hepatic, renal, cardiovascular, or metabolic disease
* History of NSAID-induced asthma, active peptic ulcer disease
* Drug or alcohol abuse within 1 year
* Pregnancy, breastfeeding, or lack of effective contraception
* Participation in another interventional clinical trial within 3 months
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