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
Verified date | November 2019 |
Source | Yiling Pharmaceutical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
China | The First Hospital of Jilin University | Chang Chun | Jilin |
Lead Sponsor | Collaborator |
---|---|
Yiling Pharmaceutical Inc. |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |