Study of Aolanti Weikang Tablets in Healthy Volunteers

NCT03358485 | Completed Phase 1

• 1 other identifier: QF-WKP-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number and grade of treatment-related adverse events (AEs)

  3 weeks

Study Arms (2)

Aolanti Weikang tablets

EXPERIMENTAL

3，6 or 8 Aolanti Weikang tablets each time,tid

Drug: Aolanti Weikang tablets

Placebo

PLACEBO COMPARATOR

3,6 or 8 tablets each time,tid

Other: Placebo

Interventions

Aolanti Weikang tablets DRUG

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

Aolanti Weikang tablets

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) :≥19 and ≤26 kg/m2
• Signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

Location

Study Officials

• Xudong Tang

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: November 30, 2017
• Study Start: December 14, 2017
• Primary Completion: April 21, 2018
• Study Completion: June 30, 2018
• Last Updated: August 15, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)