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Status unknownNCT02622230Updated Dec 14, 2015

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

A Phase 1 interventional study of Mianhuahua Flavonoids Tablets and Placebo in Healthy, sponsored by Xinjiang Uygur Pharmaceutical Co., Ltd.. Status unknown. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-14.

Sponsored by Xinjiang Uygur Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Healthy

Keywords

  • Uygur Medicine
03

In context

Lead sponsor

Xinjiang Uygur Pharmaceutical Co., Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Mianhuahua Flavonoids Tablets

    Mianhuahua Flavonoids Tablets, oral administration

    Drug: Mianhuahua Flavonoids Tablets

  • Placebo comparator
    Placebo

    Placebo, oral administration

    Drug: Placebo

Interventions

  • DrugMianhuahua 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)

  • DrugPlacebo

    Placebo to match with experimental groups

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days

Secondary outcomes

  1. Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 24h

  2. Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 24h

  3. area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 24h

  4. t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 24h

  5. Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 24h

  6. Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 24h

  7. Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 29 days

  8. Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 29 days

  9. Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 29 days

  10. area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 29 days

  11. Degree of fluctuation（DF） of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.

    Time frame: up to 29 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02622230
Lead sponsor
Xinjiang Uygur Pharmaceutical Co., Ltd.
Collaborators
Chinese Academy of Sciences
Responsible party
Sponsor
First posted
Dec 4, 2015
Start date
Dec 2015
Primary completion
Oct 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Dec 14, 2015

Study contacts

MU Dan dan
Contact
mudandan@renfu.com.cn
86-0991-3768609
YIN Hai long
Contact
yinhailong@renfu.com.cn
86-0991-3768609
QIU Fu rong
principal investigator · Shuguang Hospital affiliated with Shanghai University of TCM

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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