Clinical trial NCT02622230: Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Uygur Medicine
Lead sponsor: Xinjiang Uygur Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese Academy of Sciences
First posted: 2015-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days
Secondary outcomes:
measure: Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 24h
measure: Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 24h
measure: area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 24h
measure: t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 24h
measure: Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 24h
measure: Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 24h
measure: Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 29 days
measure: Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 29 days
measure: Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 29 days
measure: area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 29 days
measure: Degree of fluctuation（DF） of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
timeFrame: up to 29 days
Other outcomes:
Locations:
Study officials:
affiliation: Shuguang Hospital affiliated with Shanghai University of TCM
name: QIU Fu rong
role: PRINCIPAL_INVESTIGATOR
References: