Study of Aolanti Weikang Tablets in Healthy Volunteers

Qingfeng Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Functional Dyspepsia

Treatments

Drug: Aolanti Weikang tablets

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03358485

QF-WKP-101

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts 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