Gastric Ulcer, Duodenal Ulcer, Reflux Esophagitis, Assist in the eradication of Helicobacter pylori
Conditions
Interventions
Fasting-meal sequence group:In the first phase, 40 mg of konorazan hydrochloride (10 mg/tablet, 4 tablets) will be taken orally on an empty stomach
after the 7-day wash period, in the second phase, 40 mg of konorazan hydrochloride (10 mg/tablet, 4 tablets) will be taken orally after meals.
Meal-fasting sequence group:In the first phase, 40 mg of konorazan hydrochloride (10 mg/tablet, 4 tablets) will be taken orally
after the 7-day wash period, in the second phase, 40 mg of konorazan hydrochloride (10 mg/tablet, 4 tablets) will be taken on an empty stomach in the second cycle.
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy adult male subjects aged 18 to 45 (including 18 and 45 years old) (Health means that the results of examinations such as medical history, careful physical and vital signs examinations, laboratory examinations, and 12-lead electrocardiograms are normal or abnormal but have no clinical significance in the judgment of the investigator); The normal reference values for vital signs sitting measurement are as follows: Systolic blood pressure: 90~140mmHg; Diastolic blood pressure: 60~90mmHg; Pulse: 60~100 beats/minute;Respiratory rate: 16-20 times/min; Body temperature (ear temperature): 35.7?~37.5 degree C; 2. Total body weight >=50.0kg and body mass index (BMI) 18 to 26 kg/m2 (including 18.00 and 26.00, BMI=weight/height2); 3. Subjects signed the informed consent form voluntarily; 4. Subjects should take appropriate contraceptive measures from the period of administration to 3 months after drug withdrawal to avoid pregnancy of their partners; 5. Subjects have a good lifestyle and can keep good communication with the investigator and comply with the requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Subjects who have a history of drug allergy (two or more drugs) or atopic allergic disease (e.g. asthma, urticaria, eczema, dermatitis, etc.) that were clinically significant, or allergic to any known ingredients and excipients of the investigational product, TAK-438 and other PPIs drugs (e.g., Omeprazole, Lansoprazole, Ilaprazole, Esomeprazole, Rabeprazole, etc.); 2. History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents and siblings); 3. Any disease or medical history that may significantly affect the absorption, distribution, metabolism, and excretion of the drug, or any disease that may be harmful to the subject. Such as: 1) History of previous major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, enterotomy, gastric bypass, gastric dissection or gastric banding, cholecystectomy, except for appendicitis and anal prolapse surgery); 2) Evidence of liver disease or clinically significant impairment of liver function (e.g. AST, ALT or total bilirubin > 1.5 ULN) at screening; 3) History or clinical evidence of kidney disease or renal insufficiency at screening, manifested as clinically significant creatinine abnormalities or abnormal urine components (e.g. proteinuria, etc.); 4) Urinary tract obstruction or difficulty in emptying urine during the screening period; 5) Subjects who have difficulty in swallowing oral preparations. 4. History of immunodeficiency disease, including HIV antibody positive; 5. Hepatitis B virus surface antigen (HBsAg) and Hepatitis C virus (HCV) antibody are positive, or Treponema pallidum antibody is positive; 6. Subjects who suffer from severe illness within 2 weeks prior to administration; 7. Subjects who have used any prescription drugs within 4 weeks prior to administration, or any over-the-counter drugs (including chemical drugs, vitamin drugs, Chinese herbal medicines, etc.) within 2 weeks prior to administration, or have taken food that affects CYP3A4 within 48 hours prior to administration, such as Grapefruit or a drink containing grapefruit; 8. Subjects who smoked more than 10 cigarettes per day within 3 months prior to the study or could not quit smoking during the whole confinement period; 9. Subject consumes excessive amounts of alcohol within 3 month prior to the study, defined as greater than 2 units per day (1 units = 360 ml beer or 45ml spirits with 40% alcohol or 150ml wine) or the alcohol breath test is positive at screening 10. Subjects who donated blood or haemorrhage =400mL within 3 months prior to the study, or subjects who plan to donate blood during medication period and within 3 months after drug withdrawal; 11. History of drugs within 3 months prior to the study, or history of drug abuse within 12 months, or positive urine drug screen; 12. Subjects who have participated in any other clinical trial and received interventions from study drugs or medical devices within 3 month prior to this study; 13. Subjects who have special dietary requirements; 14. Other conditions that an Investigator believes are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8;AUC0-t;Cmax;Tmax;t1/2;?z;CL/F;Vd;MRT;AUC_%Extrap; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Vital signs and physical examination;Laboratory examination;ECG examination; | — |
Countries
China
Contacts
Public ContactFeng Shao
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed