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Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration

NCT05787028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-12-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AD16 5mg、10mg、20mg、30mg、40mg、60mg、80mg

Take one AD16 tablet in the morning

DRUG

AD16 placebo 5mg、10mg、20mg、30mg、40mg、60mg、80mg

Participants will take a placebo pill matching AD16 once in the morning

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • South China Center For Innovative Pharmaceuticals

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05787028 on ClinicalTrials.gov