Peptic Ulcer
Conditions
Interventions
T-R-T-R fast group:Subjects were administered the test formulation in the first cycle, the reference formulation in the second cycle, the test formulation in the third cycle, and the reference formula
R-T-R-T fast group:Subjects were administered the reference formulation in the first cycle, the test formulation in the second cycle, the reference formulation in the third cycle, and the test formula
T-R-T-R fed group:Subjects were administered the test formulation in the first cycle, the reference formulation in the second cycle, the test formulation in the third cycle, and the reference formulat
R-T-R-T fed group:Subjects were administered the reference formulation in the first cycle, the test formulation in the second cycle, the reference formulation in the third cycle, and the test formulat
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Subjects must fully understand the trial's purpose, procedures, potential risks, and benefits, voluntarily participate, and provide written informed consent before enrollment; 2) Healthy male or female participants aged 18–65 years (inclusive); 3) Body mass index (BMI) = weight (kg)/height² (m²), ranging from 19.0 to 26.0 (inclusive). Male weight >= 50.0 kg, female weight >= 45.0 kg; 4) From signing the informed consent until 3 months after trial completion, subjects (and their partners) must agree to use highly effective contraception and have no pregnancy plans; 5) Subjects must be able to communicate effectively with investigators, comprehend study requirements, and adhere to protocol-specified procedures.
Exclusion criteria
Exclusion criteria: 1) (Inquiry) Known hypersensitivity to lansoprazole, its excipients, or other proton pump inhibitors (e.g., omeprazole, esomeprazole, rabeprazole, pantoprazole), or any food/drug allergies deemed by the investigator to preclude participation; 2) (Inquiry) Clinically significant medical conditions or factors that may compromise safety or affect drug absorption, distribution, metabolism, or excretion, including but not limited to neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic, or musculoskeletal disorders; or conditions such as dysphagia; 3) (Inquiry) History of peptic ulcer/gastrointestinal bleeding, osteoporosis-related fracture risk, Clostridioides difficile diarrhea, vitamin B12 deficiency, hypomagnesemia (confirmed biochemically), acute interstitial nephritis, subacute cutaneous lupus erythematosus (SCLE), fundic gland polyps, gastrectomy/enterectomy, or atrophic gastritis; 4) (Inquiry) Major surgery within 30 days prior to dosing or planned surgery during the trial; 5) (Inquiry) Intolerance to venipuncture or history of needle/blood phobia; 6) (Inquiry) History of drug abuse or illicit drug use within 6 months prior to dosing; 7) (Inquiry) Blood donation/loss >=200 mL (excluding menstrual bleeding), transfusion, or use of blood products within 3 months prior to dosing; or plans to donate blood during the trial; 8) (Inquiry) Pregnant or lactating women; 9) (Inquiry) Unprotected sexual activity within 30 days prior to dosing without effective contraception; 10) (Inquiry) Plans to donate sperm/ova from first dose until 3 months post-trial; 11) (Inquiry) Use of prescription/non-prescription drugs, supplements, or herbal medicines within 14 days prior to dosing; 12) (Inquiry) Use of hepatic enzyme inducers (e.g., barbiturates, carbamazepine, phenytoin, glucocorticoids) or inhibitors (e.g., SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, hypnotics, verapamil, fluoroquinolones, antihistamines, HIV protease inhibitors) within 30 days prior to dosing, or any other drugs (including traditional medicines) judged by the investigator to affect pharmacokinetic assessments; 13) (Inquiry) Vaccination within 14 days prior to dosing; 14) (Inquiry) Smoking >5 cigarettes/day on average within 30 days prior to screening or inability to abstain from smoking during the trial; 15) (Inquiry) Alcohol intake >2 units/day (1 unit = 360 mL beer [5%], 45 mL liquor [40%], or 150 mL wine [12%]) within 30 days prior to screening or inability to abstain from alcohol during the trial; 16) (Inquiry) Excessive consumption of tea/coffee/caffeinated beverages (>8 cups/day; 1 cup = 250 mL) within 30 days prior to screening or inability to abstain during the trial; 17) (Inquiry) Consumption of foods/beverages that may affect drug pharmacokinetics (e.g., pitaya, mango, grapefruit, lime, starfruit, chocolate, caffeine/xanthine-containing products) within 48 hours prior to dosing; 18) (Inquiry) Special dietary requirements, non-compliance with standardized meals, or unusual diets (e.g., fasting, low-sodium) within 30 days prior to screening; 19) (Inquiry) Lactose/galactose intolerance; 20)Failure to pass screening or participation in another drug/device clinical trial within 3 months prior to dosing; 21) Clinically significant abnormalities in vital signs or physical examination; 22) Clinically significant laboratory abnormalities (hematology, biochemistry, coagulation, urinalysis, hepatitis B/C, syphilis/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, maximum plasma concentration;AUC0-t, area under the concentration-time curve from zero to the last measurable concentration;AUC0-8, area under the concentration-time curve from zero to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, time to peak concentration;t1/2, terminal elimination half-life;?z, elimination rate constant;AUC_%Extrap, percentage of residual area; | — |
Countries
China
Contacts
Public ContactChunhua Zhou
The First Hospital of Hebei Medical University
Outcome results
None listed