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

NCT03617510 | Completed Phase 1

• 1 other identifier: BALF-PAIN-1002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
2. 2.To evaluate the pharmacokinetic characteristics in healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
3. 3.To provide the basis for the dose for the follow-up clinical study.

Conditions

Pain

Keywords

Tolerance; Pharmacokinetic characteristics

Outcome Measures

Primary Outcomes (1)

• Tolerance evaluation index

  percent of subjects with adverse reactions

  up to 96.5 hours after mutil-dose

Secondary Outcomes (10)

• Tmax

  up to 96.5 hours after mutil-dose

• Peak Plasma Concentration (Cmax)

  up to 96.5 hours after mutil-dose

• t1/2

  up to 96.5 hours after mutil-dose

• Vd

  up to 96.5 hours after mutil-dose

• Mean residence time (MRT) parameter.

  up to 96.5 hours after mutil-dose

Study Arms (4)

group1

EXPERIMENTAL

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.

Drug: Felbinac Trometamol Injection; Drug: Placebos

group2

EXPERIMENTAL

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.

Drug: Felbinac Trometamol Injection; Drug: Placebos

group3

EXPERIMENTAL

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.

Drug: Felbinac Trometamol Injection; Drug: Placebos

group4

EXPERIMENTAL

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.

Drug: Felbinac Trometamol Injection; Drug: Placebos

Interventions

Felbinac Trometamol Injection 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.

Also known as: 4-Biphenylacetic Acid

group1; group2; group3; group4

Placebos 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.

Also known as: normal saline

group1; group2; group3; group4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• Physical examination, vital signs normal or no clinical significance.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shijiazhuang Yiling Pharmaceutical Co. Ltd: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yanhua Ding, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 6, 2018
• Study Start: July 10, 2018
• Primary Completion: November 5, 2018
• Study Completion: April 30, 2019
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)