Status:
COMPLETED
Study of Aolanti Weikang Tablets in Healthy Volunteers
Lead Sponsor:
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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....
Eligibility Criteria
Inclusion
- Body mass index (BMI) :≥19 and ≤26 kg/m2
- Signed written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03358485
Start Date
December 14 2017
End Date
June 30 2018
Last Update
August 15 2018
Active Locations (1)
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1
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100091