Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration - Trial NCT05787028
Access comprehensive clinical trial information for NCT05787028 through Pure Global AI's free database. This Phase 1 trial is sponsored by Xiangya Hospital of Central South University and is currently Completed. The study focuses on Alzheimer's Disease. Target enrollment is 70 participants.
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Study Focus
Sponsor & Location
Xiangya Hospital of Central South University
Timeline & Enrollment
Phase 1
Jan 30, 2019
May 31, 2020
Primary Outcome
Adverse events,Serious adverse events,Number of participants with abnormal laboratory test results,Number of participants with abnormal vital signs,Number of participants with abnormal 12-lead electrocardiogram readings,Number of participants with abnormal physical examination findings,Concomitant Medication,Tmax of AD16,Cmax of AD16,t1/2z of AD16,AUC 0-∞ of AD16,AUC 0-t of AD16,CL/F of AD16,Vd/F of AD16,λz of AD16,Mean retention time（MRT ）of AD16
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05787028
Non-Device Trial