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

NCT ID: NCT03617510

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2019-04-30

Brief Summary

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

3. To provide the basis for the dose for the follow-up clinical study.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Felbinac Trometamol Injection

Intervention Type: DRUG

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.

Placebos

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Felbinac Trometamol Injection

Intervention Type: DRUG

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.

Placebos

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Felbinac Trometamol Injection

Intervention Type: DRUG

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.

Placebos

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Felbinac Trometamol Injection

Intervention Type: DRUG

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.

Placebos

Intervention Type: DRUG

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.

Interventions

Felbinac Trometamol Injection

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.

Intervention Type: DRUG

Placebos

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.

Intervention Type: DRUG

Other Intervention Names

4-Biphenylacetic Acid; normal saline

Eligibility Criteria

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. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shijiazhuang Yiling Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

BALF-PAIN-1002

Identifier Type: -

Identifier Source: org_study_id