Study of Aolanti Weikang Tablets in Healthy Volunteers

NCT ID: NCT03358485

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2018-06-30

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.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aolanti Weikang tablets

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

Group Type: EXPERIMENTAL

Aolanti Weikang tablets

Intervention Type: DRUG

Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).

Placebo

3,6 or 8 tablets each time,tid

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Aolanti Weikang tablets

Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xudong Tang

Role: PRINCIPAL_INVESTIGATOR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

QF-WKP-101

Identifier Type: -

Identifier Source: org_study_id