Study of Aolanti Weikang Tablets in Healthy Volunteers

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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