Study of Aolanti Weikang Tablets in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Drug: Aolanti Weikang tablets
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aolanti Weikang tablets<br>3，6 or 8 Aolanti Weikang tablets each time,tid | Drug: Aolanti Weikang tablets<br>* Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).<br>|
| Placebo Comparator: Placebo<br>3,6 or 8 tablets each time,tid | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and grade of treatment-related adverse events (AEs) | All of the AE are assessed by NCI-CTCAE v4.03 | 3 weeks |