NCT03358485

Study of Aolanti Weikang Tablets in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Aolanti Weikang tablets	Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).
OTHER	Placebo	Placebo

Timeline

• Start date: 2017-12-14
• Primary completion: 2018-04-21
• Completion: 2018-06-30
• First posted: 2017-11-30
• Last updated: 2018-08-15

Locations

1 site across 1 country: China