Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration
Status:
Completed
Trial end date:
2020-05-31
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to evaluate the safety, tolerability and
pharmacokinetic characteristics of single administration of AD16 tablets in healthy adults
under fasting conditions, and the secondary objective was to preliminarily evaluate the
material balance of single administration of AD16 tablets in fasting conditions.
The study is divided into two parts: preliminary test and formal test. The formal trial was a
single-center, randomized, placebo-controlled, double-blind, dose-increasing study, with 5
dose groups (5mg, 10mg, 20mg, 30mg and 40mg, respectively).
Ten subjects (male and female) were enrolled in each dose group, of which 8 received the
experimental drug and 2 received placebo.
Urine and fecal samples were collected in the 20mg dose group for material balance
study.Urine and fecal samples were collected in the 20mg dose group for material balance
study.