[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation study of the safety and efficacy of a new Chinese medicine, Catalpol Tablets, in healthy Chinese subjects
主要目的:观察梓醇片在健康受试者单次和多次试验中的耐受性和安全性。 次要目的:评价梓醇片在健康受试者中的单次给药、多次给药的药代动力学行为和药代动力学参数,初步探索梓醇片降糖作用以及药动药效学结合研究。
[Translation] Primary objective: To observe the tolerability and safety of catalpol tablets in single and multiple trials in healthy subjects. Secondary objective: To evaluate the pharmacokinetic behavior and pharmacokinetic parameters of catalpol tablets in healthy subjects after single and multiple administrations, and to preliminarily explore the hypoglycemic effect of catalpol tablets and the pharmacokinetic-pharmacodynamic combination study.