HealthyPhase 1NCT02622230
Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects
A Phase 1 study testing Mianhuahua Flavonoids Tablets in people with Healthy, run by Xinjiang Uygur Pharmaceutical Co., Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mianhuahua Flavonoids Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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
- 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
- Conditions
- Healthy
- Being tested
- Mianhuahua Flavonoids Tablets, Placebo
- Keywords
- Uygur Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mianhuahua Flavonoids TabletsDrug
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)
PlaceboDrug
Placebo to match with experimental groups
| Study group | Role | What they receive |
|---|---|---|
| Mianhuahua Flavonoids Tablets | Experimental | Mianhuahua Flavonoids Tablets, oral administration Receives: Drug: Mianhuahua Flavonoids Tablets |
| Placebo | Placebo comparator | Placebo, oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days
Secondary outcomes (11)
Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 24h
Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 24h
area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 24h
t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 24h
Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 24h
Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 24h
Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 29 days
Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 29 days
Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 29 days
area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 29 days
Degree of fluctuation（DF） of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Measured: up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Uygur Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- QIU Fu rong, Principal investigator, Shuguang Hospital affiliated with Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622230
- Sponsor's protocol ID
- XinjiangUP-WY-201501
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02622230
- Acronym / sponsor ID
- XinjiangUP-WY-201501
- Conditions
- Healthy
- Keywords
- Uygur Medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinjiang Uygur Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Sciences
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mianhuahua Flavonoids Tablets | Experimental | Drug: Mianhuahua Flavonoids TabletsMianhuahua Flavonoids Tablets, oral administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, oral administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mianhuahua Flavonoids TabletsTolerability 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) | Drug | Mianhuahua Flavonoids Tablets |
| PlaceboPlacebo to match with experimental groups | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 24h
Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 24h
area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 24h
t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 24h
Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 24h
Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 24h
Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 29 days
Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 29 days
Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 29 days
area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 29 days
Degree of fluctuation（DF） of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.
Time frame: up to 29 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
QIU Fu rong principal investigator
Shuguang Hospital affiliated with Shanghai University of TCM
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mianhuahua Flavonoids Tablets in people with Healthy, run by Xinjiang Uygur Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MU Dan dan (86-0991-3768609, mudandan@renfu.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.