Study of Aolanti Weikang Tablets in Healthy Volunteers

Functional Dyspepsia Clinical Trial

Official title: A Single-center, Randomized, Doule Blind, Placebo-controlled, Multiple Dose Escalation Phase 1b Study to Evaluate the Safety and Tolerability of Aolanti Weikang Tablets in Healthy Volunteers

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers

Clinical Trial Description

This is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level, subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up for 14 days. No intrapatient dose-escalation is permitted. ;

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

• NCT number: NCT03358485
• Study type: Interventional
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2017
• Completion date: June 30, 2018