A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalated Phase I Clinical Study Trial to Evaluate the Tolerance and Pharmacokinetics of Felbinac Trometamol Injection in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Felbinac Trometamol Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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); Health status: no clinical histories with clinical significance about heart, liver, kidney, digestive tract, nervous system, respiratory system (such as asthma), mental disorders and metabolic abnormalities and so on; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1<br>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:11.78mg Volume:0.50ml Frequency:Once Duration:30min A total of 10 subjects, 2 subjects served as pre-test groups, given to the test drug；the remaining 8 subjects,6 received the test drug and 2 received the placebo. | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;Drug: Placebo<br>* Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: normal saline;|
| Experimental: group2<br>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:23.56mg Volume:1.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;Drug: Placebo<br>* Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: normal saline;|
| Experimental: group3<br>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:47.13mg Volume:2.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;Drug: Placebo<br>* Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: normal saline;|
| Experimental: group4<br>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:94.25mg Volume:4.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;Drug: Placebo<br>* Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: normal saline;|
| Experimental: group5<br>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:164.92mg Volume:7.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo. | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;Drug: Placebo<br>* Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: normal saline;|
| Experimental: group6<br>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:259.16mg Volume:11.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;Drug: Placebo<br>* Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: normal saline;|
| Experimental: group7<br>Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:377.00mg Volume:16.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;Drug: Placebo<br>* Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance evaluation index | percent of subjects with adverse reactions | up to 48.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | The amount of time that a drug is present at the maximum concentration in serum. | up to 48.5 hours | 
| Peak Plasma Concentration (Cmax) | The PK parameters of the plasma sample | up to 48.5 hours | 
| t1/2 | The PK parameters of the plasma sample | up to 48.5 hours | 
| Vd | The PK parameters of the plasma sample | up to 48.5 hours | 
| Mean residence time (MRT) parameter. | The PK parameters of the plasma sample | up to 48.5 hours | 
| Ke | The PK parameters of the plasma sample | up to 48.5 hours | 
| Area under the plasma concentration versus time curve (AUC0-∞) | The PK parameters of the plasma sample | up to 48.5 hours | 
| AUC0-48.5 | The PK parameters of the plasma sample | up to 48.5 hours | 
| Ae0-48.5 | The PK parameters of the urine and the stool sample | up to 48.5 hours | 
| Fe | The PK parameters of the urine and the stool sample | up to 48.5 hours | 
| CLr | The PK parameters of the urine sample | up to 48.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerance; Pharmacokinetic characteristics