Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single/ Multiple Dose Study to Assess the Safety , Tolerability, Pharmacokinetics of Mianhuahua Flavonoids Tablets After Oral Administration In Healthy Adult Subjects

The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in healthy adult subjects.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Mianhuahua Flavonoids Tablets; Drug: Placebo

Detailed Description

1. Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability.
2. Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability.
3. Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetic characteristics
4. Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetics characteristics

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: MU Dan dan; Phone Number: 86-0991-3768609; Email: mudandan@renfu.com.cn
• Study Contact Backup: Name: YIN Hai long; Phone Number: 86-0991-3768609; Email: yinhailong@renfu.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～24 kg/m2, Weight > or = 50kg
• In good health as judged by the investigator
• Agreed to take effective contraceptive measures during the test and within 6 months after the last drug administration
• Signed informed consent form and fully understood the contents, process and possible adverse reactions of the test

Exclusion Criteria:

• Pregnancy and lactation
• History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution
• Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: Including but not limited to blood system, renal disease, liver disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, or any disease and physiological conditions interfering with the results of the test
• with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected
• History of abuse of drugs, or the result of drug abuse test is positive
• Alcohol intake more than 2 units (1 unit is equal to 12 ounces or 360 ml beer, 5 ounces or 150 ml liquor, 1.5 ounces or 45 ml distilled spirits ) per day on average within 3 months before the test, or the result of alcohol test is positive
• Smoking more than 5 cigarettes per day, or using quite amount of nicotine products within 3 months before the test, or unable to stop smoking during the test
• Excessive consumption of xanthine soda drinks, more than four cups or bottles per day
• With major surgical operations and blood or blood component transfusion within 4 weeks before the test
• Severe blood loss or blood donation more than 400ml within 2 months before the test
• Participation in other drug trials within 3 months before the test
• Usage of any drugs within 2 weeks before the test, or within 5 times of drug eliminated half-life or pharmacodynamics half-life; Vaccination within 4 weeks before the test; Acceptance of biological agents within 4 months before the test
• Be otherwise unsuitable for the study, in the opinion of the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mianhuahua Flavonoids Tablets; Mianhuahua Flavonoids Tablets, oral administration	Drug: Mianhuahua Flavonoids Tablets; Tolerability Study: Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(seven dose groups:0.3g-5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD（maximum tolerated dose）/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID) Pharmacokinetic Study: Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(six dose groups: 0.9g, 1.8g, 2.7g, 3.6g, 4.5g, 5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD（maximum tolerated dose）/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID)
Placebo Comparator: Placebo; Placebo, oral administration	Drug: Placebo; Placebo to match with experimental groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of single and repeated oral administration of Mianhuahua Flavonoids Tablets as measured by the frequency of drug-related clinical adverse events in healthy adults.	Safety and tolerability will be evaluated through Composite Metrics：adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments.	Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 24h
Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 24h
area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 24h
t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 24h
Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 24h
Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 24h
Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 29 days
Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 29 days
Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 29 days
area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 29 days
Degree of fluctuation（DF） of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.	up to 29 days

Collaborators and Investigators

• Sponsor: Xinjiang Uygur Pharmaceutical Co., Ltd.
• Collaborators: Chinese Academy of Sciences
• Investigators: Principal Investigator: QIU Fu rong, Shuguang Hospital Affiliated with Shanghai University of TCM

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Uygur Medicine
• Other Study ID Numbers: XinjiangUP-WY-201501