[Translation] A phase I clinical study on the safety, tolerability, pharmacokinetics and the effect of food on pharmacokinetics of HSK45030 dispersible tablets in healthy subjects
主要目的:评价HSK45030分散片在健康受试者中的安全性和耐受性;
次要目的:
1.评价HSK45030分散片在健康受试者中的药代动力学(PK)特征;
2.评价食物对HSK45030分散片药代动力学的影响;
3.评价不同服药方式对HSK45030药代动力学的影响。
探索性目的:
1.初步探索HSK45030在人体内的代谢产物和主要排泄途径,考察尿液和粪便中HSK45030原形药物和代谢产物(如适用)的累积排泄率;
2.初步评估HSK45030对QT间期的影响。
3.初步评估HSK45030分散片的适口性。
[Translation] Primary Objective: To evaluate the safety and tolerability of HSK45030 dispersible tablets in healthy volunteers.
Secondary Objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of HSK45030 dispersible tablets in healthy volunteers.
2. To evaluate the effect of food on the pharmacokinetics of HSK45030 dispersible tablets.
3. To evaluate the effects of different routes of administration on the pharmacokinetics of HSK45030.
Exploratory Objectives:
1. To preliminarily investigate the metabolites and major excretion pathways of HSK45030 in humans, and to investigate the cumulative excretion rates of unchanged HSK45030 and metabolites (if applicable) in urine and feces.
2. To preliminarily evaluate the effect of HSK45030 on the QT interval.
3. To preliminarily evaluate the palatability of HSK45030 dispersible tablets.