CompletedNCT03235778Updated Nov 18, 2019

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

A Phase 1 interventional study of Felbinac Trometamol Injection and Placebo in Healthy, sponsored by Yiling Pharmaceutical Inc.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by Yiling Pharmaceutical Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 58
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

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

Conditions studied

Healthy

Keywords

Tolerance; Pharmacokinetic characteristics

In context

Lead sponsor

Yiling Pharmaceutical Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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;
Acute disease occurs before screening or using test drug;
Taking chocolate, any caffeine, or xanthine-rich food or drink at least 48 hours prior to the use of the study drug;
Taking any alcoholic products within 24 hours prior to the use of the study drug;
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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 58 participants (actual)

Study arms

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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo

Interventions

DrugFelbinac 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
Also known as: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane
DrugPlacebo
Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump
Also known as: normal saline

What researchers measure

Primary outcomes

Tolerance evaluation index
percent of subjects with adverse reactions
Time frame: up to 48.5 hours

Secondary outcomes

Tmax
The amount of time that a drug is present at the maximum concentration in serum.
Time frame: up to 48.5 hours
Peak Plasma Concentration (Cmax)
The PK parameters of the plasma sample
Time frame: up to 48.5 hours
t1/2
The PK parameters of the plasma sample
Time frame: up to 48.5 hours
Vd
The PK parameters of the plasma sample
Time frame: up to 48.5 hours
Mean residence time (MRT) parameter.
The PK parameters of the plasma sample
Time frame: up to 48.5 hours
Ke
The PK parameters of the plasma sample
Time frame: up to 48.5 hours
Area under the plasma concentration versus time curve (AUC0-∞)
The PK parameters of the plasma sample
Time frame: up to 48.5 hours
AUC0-48.5
The PK parameters of the plasma sample
Time frame: up to 48.5 hours
Ae0-48.5
The PK parameters of the urine and the stool sample
Time frame: up to 48.5 hours
Fe
The PK parameters of the urine and the stool sample
Time frame: up to 48.5 hours
CLr
The PK parameters of the urine sample
Time frame: up to 48.5 hours

Study locations

1 site

The First Hospital of Jilin University
Changchun, Jilin 130021, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03235778
Lead sponsor: Yiling Pharmaceutical Inc.
Responsible party: Sponsor
First posted: Aug 1, 2017
Start date: Jul 17, 2017
Primary completion: Mar 19, 2018
Completion: Jun 15, 2018
Last update: Nov 18, 2019

Study contacts

Yanhua Ding, MD

principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Felbinac trometamol

Other studies from this sponsor

Yiling Pharmaceutical Inc.

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