Study of Aolanti Weikang Tablets in Healthy Volunteers

Phase 1

Completed

• Conditions: Functional Dyspepsia
• Interventions: Drug: Aolanti Weikang tablets; Other: Placebo

• Registration Number: NCT03358485
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-11-30
• Status Verified: 2017-12
• Study Start: 2017-12-14
• Primary Completion: 2018-04-21
• Study Completion: 2018-06-30
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Body mass index (BMI) :≥19 and ≤26 kg/m2
• Signed written informed consent

Exclusion Criteria

• With in 7 days of Screening, the average number of stool > 2 times/day
• With in 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale
• At least one clinically significant abnormality based the comprehensive examination (including vital signs, physical examination, laboratory examination and others)
• Digestive diseases, or other diseases within 3 months that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator
• Smoking, alcohol abuse or drug abuse with in 3 months or drinking within 48 hours before the first administration
• History of drug or aurantium allergy
• Concomitant medication within 2 weeks prior to drug administration or any drug being used
• Participated in other clinical trials within 3 months before Screening
• Major surgery/surgical therapy for any cause within 4 weeks of Screening, or scheduled surgeries within 2 weeks after the last dose of study drug
• Subjects not agree to use adequate contraception from study entry through at least 28 days after the last dose of study drug
• Pregnancy or nursing
• Other conditions that unsuitable for enrollment considered by Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aolanti Weikang tablets	Aolanti Weikang tablets	3，6 or 8 Aolanti Weikang tablets each time,tid
Placebo	Placebo	3,6 or 8 tablets each time,tid

Primary Outcome Measures

Name	Time	Method
Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets	3 weeks	Definition of MTD: the dose level at which 3 or more subjects experienced one or more dose limited toxicities

Secondary Outcome Measures

Name	Time	Method
Number and grade of treatment-related adverse events (AEs)	3 weeks	All of the AE are assessed by NCI-CTCAE v4.03

Trial Locations

Locations (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China