Hefei Cosource Pharmaceutical, Inc.

Using pharmacokinetic parameters as endpoints, the differences in the extent and rate of absorption of diclofenac sodium sustained-release tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. and diclofenac sodium sustained-release tablets produced by Novartis Farma S.p.A. (certified by Novartis Pharma GmbH) in healthy adults were compared under fasting and high-fat meal administration conditions, and the bioequivalence of the two preparations was evaluated. Secondary objective: To evaluate the safety of the test preparation diclofenac sodium sustained-release tablets and the reference preparation diclofenac sodium sustained-release tablets in healthy subjects.

Primary objective: To evaluate the effectiveness of HYR-PB21 in postoperative analgesia after unilateral total knee replacement, using bupivacaine hydrochloride injection as a control. Secondary objectives: (1) To observe the occurrence of AEs of the test drug and the positive control drug, and to evaluate the safety of HYR-PB21 in postoperative analgesia after unilateral total knee replacement. (2) To investigate the pharmacokinetic characteristics of plasma bupivacaine of HYR-PB21 under the route of local infiltration around the joint during unilateral total knee replacement.

Primary objective: To evaluate the effectiveness of HYR-PB21 in postoperative analgesia in patients undergoing open reduction and internal fixation of unilateral ankle fractures, using bupivacaine hydrochloride injection as a control. Secondary objectives: (1) To observe the occurrence of AEs of the test drug and the positive control drug, and to evaluate the safety of HYR-PB21 in postoperative analgesia in patients undergoing open reduction and internal fixation of unilateral ankle fractures. (2) To investigate the pharmacokinetic characteristics of plasma bupivacaine in HYR-PB21 under the administration route of popliteal approach sciatic nerve block.