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

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

1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Felbinac Trometamol Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Chang Chun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
2. Be able to complete the research according to the clinical trial protocol;
3. Subjects have no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures;
4. Male and female subjects between 18 and 45 years (inclusive) of age;
5. 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);
6. 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;
7. Physical examination, vital signs normal or no clinical significance.

Exclusion Criteria:

1. Someone smoking more than 5 pieces per day within the 3 months before the trial ；
2. Allergies, such as allergies to two or more drugs, food and pollen, or known to the drug component or ethylbenzene ethyl acetate allergy;
3. 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)；
4. Blood donation or extensive blood loss (> 400 mL) within three months of the use of the study drug;
5. Taked any drug that changes liver enzyme activity 28 days prior to the use of the study drug;
6. Taked any prescription, OTC drugs, any vitamin products or herbs within 14 days prior to the use of the study drug;
7. 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;
8. Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers, such as itraconazole, ketoconazole or dronedarone;
9. There have been significant changes in diet or exercise habits recently;
10. Taked research drugs within three months prior to the use of the study drug or participating in any drug clinical trial;
11. Suffering from any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
12. ECG has clinical significance;
13. Female subjects are in lactation or serum pregnancy test are positive during screening or during the test.
14. 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);
15. hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening test positive;
16. Acute disease occurs before screening or using test drug;
17. Taking chocolate, any caffeine, or xanthine-rich food or drink at least 48 hours prior to the use of the study drug;
18. Taking any alcoholic products within 24 hours prior to the use of the study drug;
19. 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group1; 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; 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; Other Names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Drug: Placebo; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Other Names: normal saline
Experimental: group2; 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; 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; Other Names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Drug: Placebo; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Other Names: normal saline
Experimental: group3; 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; 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; Other Names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Drug: Placebo; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Other Names: normal saline
Experimental: group4; 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; 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; Other Names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Drug: Placebo; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Other Names: normal saline
Experimental: group5; 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; 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; Other Names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Drug: Placebo; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Other Names: normal saline
Experimental: group6; 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; 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; Other Names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Drug: Placebo; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Other Names: normal saline
Experimental: group7; 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; 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; Other Names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Drug: Placebo; Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump; Other Names: normal saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yiling Pharmaceutical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): March 19, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Tolerance; Pharmacokinetic characteristics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Biphenylylacetic acid
• Other Study ID Numbers: CDP-2012-009

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