Genuine Biotech Limited

Main objectives: 1 To investigate the pharmacokinetic characteristics of total radioactivity of [14C]-labeled azithromycin in whole blood and plasma of healthy male subjects; 2 To quantitatively analyze the total radioactivity in exhaled gas and excreta of healthy male subjects after oral administration of [14C]azithromycin suspension, obtain material balance data in the human body, and determine the main excretion pathway; Secondary objectives: 1 To quantitatively analyze the concentration of parent drug and metabolites (if applicable) in plasma of azithromycin and obtain the pharmacokinetic parameters of azithromycin in plasma; 2 To observe the safety of subjects after a single oral dose of [14C]azithromycin suspension. Exploratory objectives: 1 To determine the radioactive metabolite spectrum in plasma, urine and feces of healthy male subjects after oral administration of [14C]azithromycin, and identify the main metabolites, provide data on the main metabolic pathways of azithromycin in the human body, and determine the main biotransformation pathways. 2 To determine the intracellular distribution of [14C]azithromycin suspension in healthy male subjects after oral administration.

To evaluate the safety and tolerability of CL-197 capsules after a single oral administration in healthy subjects, and to evaluate the pharmacokinetic characteristics.

Primary objective: To evaluate the pharmacokinetic characteristics of single and multiple doses of azithromycin tablets in healthy Chinese adult and elderly subjects. Secondary objective: To evaluate the safety of single and multiple doses of azithromycin tablets in healthy Chinese adult and elderly subjects.