Study of Aolanti Weikang Tablets in Healthy Volunteers

Functional Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358485
• Other study ID #: QF-WKP-101
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: December 2017
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2018
• Est. primary completion date: April 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

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

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number and grade of treatment-related adverse events (AEs)	All of the AE are assessed by NCI-CTCAE v4.03	3 weeks