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Study of Aolanti Weikang Tablets in Healthy Volunteers

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Aolanti Weikang tablets
Placebo
Sponsored by
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aolanti Weikang tablets

Placebo

Arm Description

3，6 or 8 Aolanti Weikang tablets each time,tid

3,6 or 8 tablets each time,tid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2017
Last Updated
August 14, 2018
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03358485
Brief Title
Study of Aolanti Weikang Tablets in Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
April 21, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aolanti Weikang tablets
Arm Type
Experimental
Arm Description
3，6 or 8 Aolanti Weikang tablets each time,tid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3,6 or 8 tablets each time,tid
Intervention Type
Drug
Intervention Name(s)
Aolanti Weikang tablets
Intervention Description
Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets
Description
Definition of MTD: the dose level at which 3 or more subjects experienced one or more dose limited toxicities
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Number and grade of treatment-related adverse events (AEs)
Description
All of the AE are assessed by NCI-CTCAE v4.03
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xudong Tang
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiyuan Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Aolanti Weikang Tablets in Healthy Volunteers

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