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

Study Overview
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Brief Summary
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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
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Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability. Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability. Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetic characteristics Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetics characteristics

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mianhuahua Flavonoids Tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mianhuahua Flavonoids Tablets<br>Mianhuahua Flavonoids Tablets, oral administration | Drug: Mianhuahua Flavonoids Tablets<br>* 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)<br>|
| Placebo Comparator: Placebo<br>Placebo, oral administration | Drug: Placebo<br>* Placebo to match with experimental groups<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uygur Medicine