Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects
NCT ID: NCT02622230
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2015-12-31
2016-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mianhuahua Flavonoids Tablets
Mianhuahua Flavonoids Tablets, oral administration
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
Placebo, oral administration
Placebo
Placebo to match with experimental groups
Interventions
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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
Placebo to match with experimental groups
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Chinese Academy of Sciences
OTHER_GOV
Xinjiang Uygur Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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QIU Fu rong
Role: PRINCIPAL_INVESTIGATOR
Shuguang Hospital affiliated with Shanghai University of TCM
Central Contacts
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Other Identifiers
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XinjiangUP-WY-201501
Identifier Type: -
Identifier Source: org_study_id