Recipharm Strängnäs AB

Main study objectives: (1) To evaluate the non-inferiority of clinical efficacy at TOC visit (D12±2); Secondary study objectives: (1) To evaluate the microbiological efficacy and comprehensive efficacy at TOC visit (D12±2); (2) To evaluate the clinical efficacy, microbiological efficacy and comprehensive efficacy of D5+1 and D21+7; (3) To evaluate the safety of the two therapeutic drugs in the treatment of simple urinary tract infection.

The main purpose of the trial: 1. To provide the PKPD target value (f T>MIC, MIC) of pivmecillin hydrochloride tablets in patients through PK/PD, and provide a basis for setting the initial breakpoint; Secondary purpose of the trial: 1. Pharmacokinetics of pivmecillin hydrochloride tablets in the treatment of uncomplicated urinary tract infection; 2. Clinical efficacy and microbiological efficacy of pivmecillin hydrochloride tablets in the treatment of uncomplicated urinary tract infection; 3. To evaluate the safety of oral pivmecillin hydrochloride tablets in the treatment of uncomplicated urinary tract infection.

(1) To evaluate the pharmacokinetic characteristics and safety of pivmecillinam and mecillinam (active metabolite) in healthy subjects after single and multiple oral administration of pivmecillinam hydrochloride tablets; (2) To investigate the urinary excretion characteristics of mecillinam after oral administration of pivmecillinam hydrochloride tablets.