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
Overview
- Phase
- Phase 1
- Intervention
- Mianhuahua Flavonoids Tablets
- Conditions
- Healthy
- Sponsor
- Xinjiang Uygur Pharmaceutical Co., Ltd.
- Enrollment
- 60
- Primary Endpoint
- 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.
- Last Updated
- 10 years ago
Overview
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
Investigators
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
Arms & Interventions
Mianhuahua Flavonoids Tablets
Mianhuahua Flavonoids Tablets, oral administration
Intervention: Mianhuahua Flavonoids Tablets
Placebo
Placebo, oral administration
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Time Frame: Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days
Safety and tolerability will be evaluated through Composite Metrics：adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments.
Secondary Outcomes
- Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- Degree of fluctuation（DF） 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)
- area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 29 days)
- area under curve(AUC) 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)
- t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 29 days)
- 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)