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

NCT02622230 | Unknown Phase 1 DMC

• 1 other identifier: XinjiangUP-WY-201501
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Uygur Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

Mianhuahua Flavonoids Tablets

EXPERIMENTAL

Mianhuahua Flavonoids Tablets, oral administration

Drug: Mianhuahua Flavonoids Tablets

Placebo

PLACEBO COMPARATOR

Placebo, oral administration

Drug: Placebo

Interventions

Mianhuahua Flavonoids Tablets DRUG

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)

Mianhuahua Flavonoids Tablets

Placebo DRUG

Placebo to match with experimental groups

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinjiang Uygur Pharmaceutical Co., Ltd.: lead
• Chinese Academy of Sciences: collaborator

Study Officials

• QIU Fu rong

  Shuguang Hospital affiliated with Shanghai University of TCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MU Dan dan

CONTACT

86-0991-3768609; mudandan@renfu.com.cn

YIN Hai long

CONTACT

86-0991-3768609; yinhailong@renfu.com.cn

Study Design

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

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 4, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 14, 2015

Record last verified: 2015-12