Peptic ulcer, gastrointestinal ulcer bleeding
Conditions
Interventions
Sequence 1:40 mg of fumaric acid voronolase injection (i.e., 20 mg bid, at intervals of 6h +/- 5 min, Day 1) 20 mg (Day 2 & 3, qd), ivd, for continuous administration for 3 days.
Sequence 2:Fumaric acid vonoprazan injection 40mg (Day 1) 20mg (Day 2 & 3), ivd, qd, continuous administration for 3 days.
Sequence 3:Fumaric acid vonoprazan injection 40mg, ivd, qd, continuous administration for 3 days.
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate and sign an informed consent form; 2.Healthy adult participants aged between 18 and 50 years old (including 18 and 50 years old), regardless of gender; 3.Body mass index (BMI)=weight (kg)/height 2 (m^2). The BMI ranges from 18.0 to 28.0 kg/m^2, including critical values; 4.The subjects have a good lifestyle and are able to maintain good communication with the researchers and comply with various requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1.Individuals with a clinically significant history of drug allergies or known allergies to investigational drug ingredients and excipients, or P-CAB drugs (such as vorolazone fumarate), PPIs drugs (such as omeprazole, lansoprazole, eprazole, esomeprazole, rabeprazole, etc.); 2. Abnormal vital signs, blood routine, blood biochemistry, urine dry chemistry+urine sediment quantification, 12 lead electrocardiogram, eight item infection screening, four item coagulation+D-dimer examination, etc., which have clinical significance; 3. Individuals with a history of severe heart, lung, liver, kidney, blood, digestive system, endocrine, immune, skin, neurological or psychiatric diseases within the past 5 years, or those who have undergone surgery within 3 months; 4. Individuals who have received attenuated live vaccines within 30 days prior to the first administration (excluding inactivated influenza vaccines such as seasonal influenza vaccines for injection), or those who plan to receive vaccines during the study period; 5. Individuals with a history of drug abuse or positive drug screening tests within the past 5 years; 6. Positive results of alcohol breath test, or heavy drinkers in the past 3 months (drinking more than 14 units of alcohol per week: 1 unit=about 285mL of beer, or about 25mL of spirits, or about 100mL of wine); 7. Unable to follow a unified diet (such as intolerance to standard meals); 8. Individuals who have taken CYP3A4 enzyme strong inhibitors (such as ketoconazole, itraconazole, etc.) or CYP3A4 enzyme strong inducers (such as rifampicin, carbamazepine, phenytoin sodium, etc.) within 30 days before the first administration; 9.Using any prescription medication within 4 weeks before the first administration, using any over-the-counter medication (including chemicals, health products, vitamin drugs, traditional Chinese herbs, etc.) within 2 weeks before the first administration, or taking foods that affect CYP3A4 within 48 hours before administration, such as grapefruit or beverages containing grapefruit; 10. Individuals who consume excessive amounts of tea, coffee, or caffeinated beverages within 3 months prior to the first administration (8 or more cups per day, 1 cup=250mL); 11. Smoking = 5 cigarettes per day within 3 months prior to the first administration, or unwilling to stop using any tobacco products during the trial period; 12. Individuals who have participated in other clinical trials within 3 months prior to the first administration of medication; 13. Individuals who donate blood or experience bleeding for other reasons within the first 3 months prior to the first administration, resulting in a total blood loss of = 400mL (excluding physiological bleeding in females); 14. Difficulty in blood collection, with a history of fainting from needles and blood; 15.Pregnant or lactating women, as well as those who have a pregnancy plan, sperm or egg donation plan from the research period to 3 months after the end of the trial, and are unwilling to use a medically recognized contraceptive method (such as an intrauterine device or condom) during the trial period; 16.Other subjects deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indicators; | — |
Countries
China
Contacts
Public ContactYang Hui
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed