- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617510
A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China
July 1, 2020 updated by: Shijiazhuang Yiling Pharmaceutical Co. Ltd
A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose,Dose-escalated Phase I Clinical Study Trial to Evaluate the Tolerance and Pharmacokinetics of Felbinac Trometamol Injection in Healthy Subjects
- To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
- To evaluate the pharmacokinetic characteristics in healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
- To provide the basis for the dose for the follow-up clinical study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130021
- The First Hospital of Jilin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
- Be able to complete the research according to the clinical trial protocol;
- Subjects have no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures;
- Male and female subjects between 18 and 45 years (inclusive) of age;
- Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg.Body Mass Index (BMI) 18 to 28 kg/m2 (inclusive);
- Physical examination, vital signs normal or no clinical significance.
Exclusion Criteria:
- Someone smoking more than 5 pieces per day within the 3 months before the trial ;
- Allergies, such as allergies to two or more drugs, food and pollen, or known to the drug component or ethylbenzene ethyl acetate allergy;
- Having a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 units = beer 285 mL, or 25 mL of spirits, or 100 mL of wine);
- Blood donation or extensive blood loss (> 400 mL) within three months of the use of the study drug;
- Taked any drug that changes liver enzyme activity 28 days prior to the use of the study drug;
- Taked any prescription, OTC drugs, any vitamin products or herbs within 14 days prior to the use of the study drug;
- Two weeks before the trial took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, and other avtivites that affect drug absorption, distribution, metabolism, excretion and so on;
- Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers, such as itraconazole, ketoconazole or dronedarone;
- There have been significant changes in diet or exercise habits recently;
- Taked research drugs within three months prior to the use of the study drug or participating in any drug clinical trial;
- Suffering from any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
- ECG has clinical significance;
- Female subjects are in lactation or serum pregnancy test are positive during screening or during the test.
- Clinical laboratory tests are abnormal and have clinical significance, or other clinical findings showing clinically significant diseases (including but not limited to gastrointestinal, renal, liver, nerves, blood, endocrine, neoplasms, lungs, immunizations, mental or heart Cerebrovascular disease);
- hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening test positive;
- Acute disease occurs before screening or using test drug;
- Taking chocolate, any caffeine, or xanthine-rich food or drink at least 48 hours prior to the use of the study drug;
- Taking any alcoholic products within 24 hours prior to the use of the study drug;
- Alcohol or drug screening positive or drug abuse history over the past five years or 3 months before the trial used by drug users.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: group1
Generic name:Felbinac Trometamol Injection;Placebo:normal saline Dosage form:Injection Dosage:47.13mg
Volume:2.00ml
Frequency:Multi-dose after single-dose Duration:5 days A total of 12 subjects,10 received the test drug and 2 received the placebo.
|
Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours.
It means the drug was given 3 times on D3 and D4,once on D5.
Other Names:
Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.
Other Names:
|
EXPERIMENTAL: group2
Generic name:Felbinac Trometamol Injection;Placebo:normal saline Dosage form:Injection Dosage:94.25mg
Volume:4.00ml
Frequency:Multi-dose after single-dose Duration:5 days A total of 12 subjects,10 received the test drug and 2 received the placebo.
|
Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours.
It means the drug was given 3 times on D3 and D4,once on D5.
Other Names:
Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.
Other Names:
|
EXPERIMENTAL: group3
Generic name:Felbinac Trometamol Injection;Placebo:normal saline Dosage form:Injection Dosage:188.50mg
Volume:8.00ml
Frequency:Multi-dose after single-dose Duration:5 days A total of 12 subjects,10 received the test drug and 2 received the placebo.
|
Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours.
It means the drug was given 3 times on D3 and D4,once on D5.
Other Names:
Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.
Other Names:
|
EXPERIMENTAL: group4
Generic name:Felbinac Trometamol Injection;Placebo:normal saline Dosage form:Injection Dosage:259.16mg
Volume:11.00ml
Frequency:Multi-dose after single-dose Duration:5 days A total of 12 subjects,10 received the test drug and 2 received the placebo.
|
Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours.
It means the drug was given 3 times on D3 and D4,once on D5.
Other Names:
Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance evaluation index
Time Frame: up to 96.5 hours after mutil-dose
|
percent of subjects with adverse reactions
|
up to 96.5 hours after mutil-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: up to 96.5 hours after mutil-dose
|
The amount of time that a drug is present at the maximum concentration in serum.
|
up to 96.5 hours after mutil-dose
|
Peak Plasma Concentration (Cmax)
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
t1/2
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
Vd
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
Mean residence time (MRT) parameter.
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
Ke
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
Area under the plasma concentration versus time curve (AUC0-∞)
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
AUC0-48
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
Ae0-48
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the urine and the stool sample
|
up to 96.5 hours after mutil-dose
|
AUC0-last
Time Frame: up to 96.5 hours after mutil-dose
|
The PK parameters of the plasma sample
|
up to 96.5 hours after mutil-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 10, 2018
Primary Completion (ACTUAL)
November 5, 2018
Study Completion (ACTUAL)
April 30, 2019
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (ACTUAL)
August 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2020
Last Update Submitted That Met QC Criteria
July 1, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BALF-PAIN-1002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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