PU,peptic ulcer
Conditions
Interventions
KC group:In the first cycle, the test formulation was taken on an empty stomach. In the second cycle, the test formulation was taken after a meal.
RT group:Screen the qualified subjects and administer the drug on an empty stomach for 7 consecutive days each cycle. According to the randomization table for
TR group:Screen the qualified subjects and administer the drug on an empty stomach for 7 consecutive days each cycle. According to the randomization table for
CK group:In the first cycle, the test formulation was taken after meals
in the second cycle, it was taken on an empty stomach.
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Healthy male or female participants aged between 18 and 45 years old (inclusive of the boundary value; those over 45 years old during the trial period will not be excluded); 2. The weight of male participants in the trial should be >= 50.0 kg, and the weight of female participants should be >= 45.0 kg. The body mass index (BMI = weight (kg) / height (m)^2) should fall within the range of 19.0 to 26.0 kg/m^2 (inclusive of the boundaries); 3. The trial participants voluntarily adopted effective contraceptive measures (including those of their partners) from the screening stage until 6 months after the last administration of the study drug, and had no plans for egg donation (sperm donation) in the following 6 months; 4. Those who voluntarily participate and sign the informed consent form, and are able to follow the research protocol and complete the trial; 5. The trial participants who participated in the PK/PD study were able to tolerate the insertion of the nasogastric pH probe, and at the baseline screening, the pH was less than 2.5 (this does not apply to the food influence study).
Exclusion criteria
Exclusion criteria: 1.Those who have had an allergic reaction to proton pump inhibitor drugs (such as omeprazole, rabeprazole, etc. - PPIs), or to any of their active ingredients or excipients; those who have had an allergic reaction to two or more drugs, foods, etc.; those with an allergic constitution. 2.Those with special dietary requirements and who cannot accept the uniform diet; 3.Those with a history of swallowing difficulties, sinusitis, nasal septum deviation, esophageal stenosis, or esophageal varices are not suitable for endoscopic tube insertion, or those who cannot tolerate endoscopic tube insertion; 4.14C - Those who tested positive for the urea breath test; 5.Those with a history of affecting drug absorption or influencing the pH in the stomach (such as gastroesophageal reflux disease, Zollinger-Ellison syndrome, gastric/duodenal ulcers, atrophic gastritis, etc.) or a history of digestive tract surgery (such as gastrectomy, gastro-intestinal anastomosis, vagotomy, etc.); 6.Anyone with chronic or severe diseases of the endocrine system, urinary system, digestive system, blood and lymphatic system, respiratory system, cardiovascular system, nervous system, mental disorders, or musculoskeletal system, and whose abnormal conditions are judged by the research doctor to have clinical significance; 7.Exclude those who consumed excessive amounts (more than 8 cups, with 1 cup equal to 250 mL) of tea, coffee or caffeinated beverages every day within the previous 3 months; or those who consumed foods or beverages rich in caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before taking medication; 8.Exclude those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine), or those who were unable to abstain from alcohol until the end of the trial, or those whose alcohol breath test result was > 0 mg/100 mL during the screening period. 9.Those who smoked more than 5 cigarettes per day within the previous 3 months, or those who did not agree to stop using any tobacco products from the screening period until the end of the trial; 10.Those who have used any medication (including prescription drugs, over-the-counter drugs, vitamin supplements or herbal remedies) or health supplements within 14 days prior to taking the medicine; 11. Those who have used any drugs that interact with lansoprazole or alter liver enzyme activity within 30 days before taking the medicine (such as azelastine sulfate, rilpivirine hydrochloride, theophylline, digoxin methyl ester, itraconazole, gefitinib, bosutinib, tyrosine kinase inhibitors, magnesium oxide, binimetinib mesylate, methotrexate, diazepam, warfarin, sucralfate, acetaminophen, clopidogrel, terfenadine, astemizole, quinidine, pimozide, cisapride, carbamazepine, phenobarbital, efavirenz, ergot alkaloids, rifabutin, rifampicin, ritonavir, St. John's wort, everolimus, fluconazole, phenytoin, anticoagulants, benzodiazepines, sirolimus, cyclosporine, tacrolimus, opioids, statins, sulfonylureas, vinca alkaloids, methadone, non-steroidal anti-inflammatory drugs, omeprazole, cimetidine, digoxin, indinavir, macrolide antibiotics, mycophenolic acid, prednisone, ranitidine, oral contraceptives, antiretroviral drugs, etc.) or drugs with pH-dependent absorption pharmacokinetic characteristics or long half-life drugs; 12.Those who had a history of drug abuse within the past 6 months before taking the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (Cmax, AUC0-t, AUC0-8);First dose AUC0-t, AUC0-8 and the AUC0-t,ss of the 7th dose, the percentage decrease in gastric integrated acidity relative to baseline within 24 hours for the first dose and the 7th dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators (blood routine, urine routine, blood biochemistry, coagulation function); | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed