None listed
Conditions
Interventions
Fasting test: T-R group:Take the test preparation (T) orally on an empty stomach, swallowing the entire tablet of 20mg (1 tablet) and consuming it with approximately 240mL of warm water. After 3 days,
Fasting test: R-T group:Take the reference preparation (R) orally on an empty stomach, swallowing the entire tablet and consuming it with approximately 240mL of warm water. After 3 days, proceed with
Postprandial test: T-R group:Orally administer 20mg (1 tablet) of the test formulation (T) within 30 minutes +/- 0.5 minutes after a high-fat meal, swallowing the entire tablet and consuming it with a
Postprandial test: R-T group:Take orally 20mg (1 tablet) of the reference preparation (R) within 30 minutes +/- 0.5 minutes after a high-fat meal, swallowing the entire tablet and consuming it with ap
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female; 2. Age >=18 years old (including the critical value); 3. Male weight >=50kg, female weight >=45kg, 18.5 kg/m ² <= body mass index (BMI) <=26.0 kg/m ² [BMI= weight (kg)/height 2 (m ²)]; 4. During the screening period, effective contraceptive measures (including the partner of the subject) were taken within 3 months after the end of the study, and one or more contraceptive measures were ensured to be used in sexual life during this period, and there were no plans for sperm or egg donation; 5. Before the trial, voluntarily sign the informed consent form, fully understand the content, process and possible adverse reactions of the trial, and agree and have the ability to participate in all drug administration and examinations as required by the trial protocol;
Exclusion criteria
Exclusion criteria: 1. Have had or are currently suffering from diseases that researchers consider clinically serious, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, hematology, immunology, psychiatry, and metabolic disorders, or other diseases that can interfere with the test results (e.g. Those with liver dysfunction, renal insufficiency, malignant tumors, hyperkalemia, acute renal failure, Addison's disease, etc. 2. Those with serum potassium >5.0 mmol/L; 3. Those who have a history or are currently suffering from chronic or active digestive tract diseases such as gastrointestinal perforation, gastrointestinal fistula, esophageal diseases, gastritis, gastrointestinal ulcers, enteritis, gastroesophageal reflux, pancreatitis, irritable bowel syndrome, active gastrointestinal bleeding or have undergone digestive tract surgery, and whom researchers believe still have clinical significance at present; Or those who have experienced digestive tract symptoms (diarrhea, constipation, nausea, vomiting, irregular defecation, or alternating episodes of diarrhea and constipation) within 7 days before the first use of the study drug, and whom the researcher deems unsuitable to participate in the trial; 4. Those who have a history of allergies to drugs, foods or other substances that researchers have determined to be of clinical significance, or are allergic to fineridone, or are allergic to mineralocorticoid receptor antagonists (such as epleridone); 5. Those who have undergone surgery within three months prior to the first use of the study drug, or plan to undergo surgery during the trial period; 6. Those who have used any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines), health supplements and functional vitamins within 14 days prior to the first use of the study drug; 7. Strong CYP3A4 inhibitors (such as itraconazole, ketoconazole, ritonavir, nefinavir, cobisumab, clarithromycin, terithromycin, nefazolidone) have been used or are planned to be used during the trial period within 30 days before the first administration of the study drug or less than 7 half-lives from the first administration of the study drug in this study (whichever is the longest) And medium-potency inducers (such as rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort), as well as efaviren or other medium-potency CYP3A4 inducers, drugs that increase serum potassium [potassium-sparing diuretics (such as amiloride, triamterene), other mineralocorticoid receptor antagonists (MRA), Such as epirazone, isalidone, spironolactone, canlidone, etc., potassium supplements (such as potassium chloride, potassium citrate, etc.), antibacterial drugs containing trimethoprim or trimethoprim/sulfamethoxazole, antihypertensive drugs [angiotensin-converting enzyme inhibitors (ACEi class) Such as benazepril, fosinopril, perindopril, enalapril, captopril), angiotensin II receptor antagonists (ARB class, such as losartan, valsartan, irbesartan, telmisartan, Candesartan, olmesartan), etc. 8. Those who have been enrolled in any clinical trial within the three months prior to screening and have used any clinical research drugs or received medical device intervention; 9. Those who have donated blood, received a blood transfusion or used blood products within three months before taking the study drug for the first time, or have lost more than 400mL of blood (excluding blood loss during normal menstr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z;Tmax;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed