Reflux esophagitis and duodenal ulcers
Conditions
Interventions
Experimental group:A single fasting oral dose of 15 mg midazolam maleate tablets was administered on day 1 of the trial, a single fasting oral dose of 20 mg keplasen hydrochloride tablets was administ
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. subjects fully understand the purpose, content, process and possible adverse effects of the trial, volunteer to be subjects, and sign the informed consent form prior to the commencement of any trial procedure; 2. healthy men or women aged 18-45 years (including 18 years and 45 years) (healthy means that the results of all tests related to the trial, such as past history questioning, physical examination, vital signs, laboratory tests (blood, urine, blood biochemistry and coagulation function tests) and 12-lead electrocardiogram, are normal or abnormal but not clinically significant in the judgment of the investigator); 3. weight >=50.0kg for men and >=45.0kg for women; body mass index (BMI) within the range of 19~26kg/m2 (including the critical value), BMI=weight (kg)/height2 (m2); 4. subjects (including partners) are willing to have no birth plan, no sperm or egg donation plan, and voluntarily use effective contraception from the time of signing the informed consent to 3 months after the last administration of the test drug; 5. subjects are able to communicate well with the investigator and understand and comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1. subjects with a history of allergy to keplasen, midazolam, or any of the test drug components, or known allergens, or a history of atopic anaphylactic diseases, or drug allergy; 2. subjects have a family history of long QT syndrome (grandparents, parents, and siblings); 3. subjects have a history of neurological, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal or other systemic diseases, infectious diseases, or diseases of the vital organs that, in the judgment of the investigator, make participation in the trial inappropriate 4. subjects have any disease or history of disease that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or have any condition that may pose a hazard to subjects, such as: (1) subjects have inflammatory bowel disease, gastric ulcers, duodenal ulcers, gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant gastrointestinal abnormalities; (2) subjects have a prior history of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric division of said or gastric pouch banding, cholecystectomy, with the exception of appendicitis surgery and prolapse); (3) subjects with liver disease or a history or evidence of hepatic insufficiency (e.g., AST, ALT, or total bilirubin > 1.5 times ULN) at screening; (4) subject have renal disease or a history or evidence of renal insufficiency at screening as evidenced by clinically significant creatinine abnormalities or abnormal urine composition (e.g., proteinuria, etc.); (5) urinary obstruction or difficult urinary emptying during screening 5. subjects are unable to tolerate venipuncture; or have a history of needle and blood-sickness; 6. female participants have used oral contraceptives within 30 days prior to screening; or have used long-acting estrogen or progestin injections or buried tablets within 6 months prior to screening; 7. female participants are breastfeeding or pregnant; or have a positive blood pregnancy test; 8. subjects have a history of substance abuse or drug use within 3 years prior to screening; or have a positive urine substance abuse screen; 9. subjects have undergone a major surgical procedure within 3 months prior to screening, or are scheduled to undergo a procedure during the trial; 10. subjects have donated blood (including component blood) or lost a significant amount of blood (>=400mL, except for physiologic blood loss in females), or received a blood transfusion or used blood products within 3 months prior to screening 11. subjects have smoked an average of more than 5 cigarettes per day in the 3 months prior to screening; or are unable to stop using any tobacco products during the trial; 12. subjects have consumed excessive amounts of tea, coffee, and caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) per day during the 3 months prior to screening; 13. subjects have consumed an average of greater than 14 units of alcohol per week (1 unit of alcohol contains approximately 18 milliliters of alcohol ˜ 355 mL of beer or 45 mL of 40% alcohol by volume or 150 mL of wine) in the 3 months prior to screening; or are unable to discontinue alcohol consumption during the test period; or have a positive breath test result for alcohol; 14. subjects have used a test drug or participated in another clinical trial within 3 months prior to scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators; | — |
Countries
China
Contacts
Public ContactShuixin Yang
Huzhou Central Hospital
Outcome results
None listed