Clinical trial NCT03617510: A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Tolerance; Pharmacokinetic characteristics
Lead sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Tolerance evaluation index
timeFrame: up to 96.5 hours after mutil-dose
Secondary outcomes:
measure: Tmax
timeFrame: up to 96.5 hours after mutil-dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 96.5 hours after mutil-dose
measure: t1/2
timeFrame: up to 96.5 hours after mutil-dose
measure: Vd
timeFrame: up to 96.5 hours after mutil-dose
measure: Mean residence time (MRT) parameter.
timeFrame: up to 96.5 hours after mutil-dose
measure: Ke
timeFrame: up to 96.5 hours after mutil-dose
measure: Area under the plasma concentration versus time curve (AUC0-∞)
timeFrame: up to 96.5 hours after mutil-dose
measure: AUC0-48
timeFrame: up to 96.5 hours after mutil-dose
measure: Ae0-48
timeFrame: up to 96.5 hours after mutil-dose
measure: AUC0-last
timeFrame: up to 96.5 hours after mutil-dose
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References: