Study of Aolanti Weikang Tablets in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT03358485
• Recruitment Status: Completed
• First Posted: November 30, 2017
• Last Update Posted: August 15, 2018
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Information provided by (Responsible Party): Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Condition or disease	Intervention/treatment	Phase
Functional Dyspepsia	Drug: Aolanti Weikang tablets; Other: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 14, 2017
• Actual Primary Completion Date: April 21, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aolanti Weikang tablets; 3，6 or 8 Aolanti Weikang tablets each time,tid	Drug: Aolanti Weikang tablets; Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).
Placebo Comparator: Placebo; 3,6 or 8 tablets each time,tid	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Number and grade of treatment-related adverse events (AEs) [ Time Frame: 3 weeks ]
   All of the AE are assessed by NCI-CTCAE v4.03

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

China, Beijing

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing, China, 100091

Sponsors and Collaborators

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Investigators

• Principal Investigator: Xudong Tang; Xiyuan Hospital of China Academy of Chinese Medical Sciences

More Information

• Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• ClinicalTrials.gov Identifier: NCT03358485
• Other Study ID Numbers: QF-WKP-101
• First Posted: November 30, 2017
• Last Update Posted: August 15, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dyspepsia; Signs and Symptoms, Digestive