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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02622230
Other study ID # XinjiangUP-WY-201501
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received November 23, 2015
Last updated December 10, 2015
Start date December 2015
Est. completion date November 2016

Study information

Verified date December 2015
Source Xinjiang Uygur Pharmaceutical Co., Ltd.
Contact MU Dan dan
Phone 86-0991-3768609
Email mudandan@renfu.com.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Xinjiang Uygur Pharmaceutical Co., Ltd. Chinese Academy of Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 24h No
Secondary Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 24h No
Secondary area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 24h No
Secondary t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 24h No
Secondary Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 24h No
Secondary Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 24h No
Secondary Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 29 days No
Secondary Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 29 days No
Secondary Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 29 days No
Secondary area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 29 days No
Secondary Degree of fluctuation(DF) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. up to 29 days No
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