Gastric Ulcer, Duodenal Ulcer, Reflux Esophagitis, Assist in the eradication of Helicobacter pylori
Conditions
Interventions
Group 6:H008 tablets 80mg (8 tablets) or placebo 80mg (8 tablets) or positive control drug 30mg (1 tablet), all single dose
Group 1:H008 tablets 5mg (1/2 tablet), single dose
Group 2:H008 tablets 10mg (1 tablets) or placebo 10mg (1 tablets) or positive control drug 30mg (1 tablet), all single dose
Group 3:H008 tablets 20mg (2 tablets) or placebo 20mg (2 tablets) or positive control drug 30mg (1 tablet), all single dose
Group 4:H008 tablets 40mg (4 tablets) or placebo 40mg (4 tablets) or positive control drug 30mg (1 tablet), all single dose
Group 5:H008 tablets 60mg (6 tablets) or placebo 60mg (6 tablets) or positive control drug 30mg (1 tablet), all single dose
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult volunteers aged 18 to 45 (including 18 and 45 years old) (Health means that the results of ex aminations 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), males and females each account for half of the total number of the volunteers; The normal reference values for vital signs sitting measurement are as follows: Systolic blood pressure: 90~140 mmHg; Diastolic blood pressure: 60~90 mmHg; Heart rate: 60~100 beats/minute; Respiration rate: 16~20 times/min; Body temperature (ear temperature): 35.7 to 37.5 degree C; 2. Total body weight >=50.0 kg for males and >=45.0 kg for females and body mass index (BMI) 18 to 26 kg/m2, BMI=weight/height2); 3. Subjects sign the informed consent form voluntarily; 4. Subjects should take appropriate contraceptive measures from the period of administration to 3 months after withdrawal to avoid pregnancy of themselves or their partners; 5. Subjects have a good lifestyle, can keep good communication with the investigators and comply with the requirements of clinical study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have a history of drug allergy 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) Subjects who have inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal / rectal bleeding, persistent nausea or other clinically significant gastrointestinal abnormalities; 2) History of previous gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, enterotomy, gastric bypass, gastric dissection or gastric banding, cholecystectomy, except for appendicitis and anal prolapse surgery); 3) Evidence of liver disease or clinically significant impairment of liver function (e.g. AST, ALT or bilirubin > 1.5 fold ULN) at screening; 4) 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.); 5) Urinary tract obstruction or difficulty in emptying urine during the screening period; 6) 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 positive breath test 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 within 3 month prior to this trail; 13. Females who are pregnant or lactating; 14. Subjects who have special dietary requirements; 15. Other conditions that an Investigator believes are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf;AUClast;Cmax;Tmax;t1/2;Kel;MRT;CL/F;Vd//F;AUC_%Extrap;Ae;CLr;Changes in gastric pH value within 24h before administration and 48h after administration, percentage of time when pH value>3, pH value>4, and pH value>5; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Vital signs and physical examination;Laboratory examination;Serum pregnancy;ECG examination; | — |
Countries
China
Contacts
Public ContactFeng Shao
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed