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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235778
• Other study ID #: CDP-2012-009
• Status: Completed
• Phase: Phase 1
• Start date: July 17, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: November 2019
• Source: Yiling Pharmaceutical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 15, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Chang Chun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yiling Pharmaceutical Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance evaluation index	percent of subjects with adverse reactions	up to 48.5 hours
Secondary	Tmax	The amount of time that a drug is present at the maximum concentration in serum.	up to 48.5 hours
Secondary	Peak Plasma Concentration (Cmax)	The PK parameters of the plasma sample	up to 48.5 hours
Secondary	t1/2	The PK parameters of the plasma sample	up to 48.5 hours
Secondary	Vd	The PK parameters of the plasma sample	up to 48.5 hours
Secondary	Mean residence time (MRT) parameter.	The PK parameters of the plasma sample	up to 48.5 hours
Secondary	Ke	The PK parameters of the plasma sample	up to 48.5 hours
Secondary	Area under the plasma concentration versus time curve (AUC0-8)	The PK parameters of the plasma sample	up to 48.5 hours
Secondary	AUC0-48.5	The PK parameters of the plasma sample	up to 48.5 hours
Secondary	Ae0-48.5	The PK parameters of the urine and the stool sample	up to 48.5 hours
Secondary	Fe	The PK parameters of the urine and the stool sample	up to 48.5 hours
Secondary	CLr	The PK parameters of the urine sample	up to 48.5 hours