Clinical trial NCT03358485: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Functional Dyspepsia
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets
timeFrame: 3 weeks
Secondary outcomes:
measure: Number and grade of treatment-related adverse events (AEs)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Xudong Tang
role: PRINCIPAL_INVESTIGATOR
References: