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HealthyPhase 1NCT03235778

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

A Phase 1 study testing Felbinac Trometamol Injection in people with Healthy, run by Yiling Pharmaceutical Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Felbinac Trometamol Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteChina
Study dates
17 Jul 2017to 15 Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

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

  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
Conditions
Healthy
Being tested
Felbinac Trometamol Injection, Placebo
Keywords
Tolerance; Pharmacokinetic characteristics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Felbinac Trometamol InjectionDrug

    Also called 4-Biphenylacetic Acid Trishydroxymettiylaminometnane

    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

  • PlaceboDrug

    Also called normal saline

    Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump

Study groups in NCT03235778
Study groupRoleWhat they receive
group1ExperimentalGeneric 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.
Receives: Drug: Felbinac Trometamol Injection; Drug: Placebo
group2ExperimentalGeneric 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.
Receives: Drug: Felbinac Trometamol Injection; Drug: Placebo
group3ExperimentalGeneric 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.
Receives: Drug: Felbinac Trometamol Injection; Drug: Placebo
group4ExperimentalGeneric 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.
Receives: Drug: Felbinac Trometamol Injection; Drug: Placebo
group5ExperimentalGeneric 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.
Receives: Drug: Felbinac Trometamol Injection; Drug: Placebo
group6ExperimentalGeneric 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
Receives: Drug: Felbinac Trometamol Injection; Drug: Placebo
group7ExperimentalGeneric 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
Receives: Drug: Felbinac Trometamol Injection; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerance evaluation index

    percent of subjects with adverse reactions

    Measured: up to 48.5 hours

Secondary outcomes (11)

  1. Tmax

    The amount of time that a drug is present at the maximum concentration in serum.

    Measured: up to 48.5 hours

  2. Peak Plasma Concentration (Cmax)

    The PK parameters of the plasma sample

    Measured: up to 48.5 hours

  3. t1/2

    The PK parameters of the plasma sample

    Measured: up to 48.5 hours

  4. Vd

    The PK parameters of the plasma sample

    Measured: up to 48.5 hours

  5. Mean residence time (MRT) parameter.

    The PK parameters of the plasma sample

    Measured: up to 48.5 hours

  6. Ke

    The PK parameters of the plasma sample

    Measured: up to 48.5 hours

  7. Area under the plasma concentration versus time curve (AUC0-∞)

    The PK parameters of the plasma sample

    Measured: up to 48.5 hours

  8. AUC0-48.5

    The PK parameters of the plasma sample

    Measured: up to 48.5 hours

  9. Ae0-48.5

    The PK parameters of the urine and the stool sample

    Measured: up to 48.5 hours

  10. Fe

    The PK parameters of the urine and the stool sample

    Measured: up to 48.5 hours

  11. CLr

    The PK parameters of the urine sample

    Measured: up to 48.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2017
  2. Study start17 Jul 2017
  3. Primary completion19 Mar 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235778
Sponsor's protocol ID
CDP-2012-009
Status last verified
Nov 2019
First submitted
17 Jul 2017
Last updated
18 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Felbinac Trometamol Injection in people with Healthy, run by Yiling Pharmaceutical Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerance evaluation index (time frame: up to 48.5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.

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