Peptic ulcer disease
Conditions
Interventions
Group A:The test preparation (polyprex zinc granules, specification 75mg) was taken on an empty stomach in the first cycle, and the reference preparation (Promac? granules 15%) was taken on an empty s
Group B:Cycle I oral fasting reference preparation (Plamac ? granules 15%), cycle II fasting oral test preparation (polyprex zinc granules, specification 75mg).
Group C:In Cycle I, Group C subjects were orally administered the test preparation (polypreci zinc granules, specification 75mg) after meals, and in Cycle II Group C, subjects were orally ordained wit
Group D:In Cycle I, Group D subjects were orally administered a reference preparation (Plamac ? granules 15%), and in Cycle II Group D, subjects were orally administered a test preparation (polyprepol
Sponsors
Henan Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Healthy subjects (including the threshold value) aged 18 years and above, both male and female; 2.Weight: Male >=50kg, female >=45kg, and body mass index (BMI) of 19.0-26.0kg/m^2 (including the threshold value); 3.Voluntarily sign a written informed consent form; 4.Able to maintain good communication with researchers and comply with requirements of clinical trials.
Exclusion criteria
Exclusion criteria: 1.Individuals who have history or existing chronic or serious diseases of the blood system, circulatory system, digestive system, urinary system, nervous system, immune system, endocrine system, mental disorders, metabolic disorders or any other system that may affect the results of the study, including respiratory diseases; 2.Those who have undergone major surgical operations within the 6 months prior to screening, or who plan to undergo surgery during the study period, and those who have undergone operations that affect drug absorption, distribution, metabolism, excretion, except for appendicitis and hernia repair operations, or have diseases that affect drug absorption, distribution, metabolism, excretion; 3.Use of any prescription drugs ,such as blood pressure medications in the 4 weeks prior to screening, or use of any over-the-counter drugs including vitamins, herbal supplements in the 2 weeks prior to screening, or use of food that affects metabolism, such as grapefruit or drinks containing grapefruit in the 2 weeks prior to screening; Or the subjects refused to stop eating xanthine-rich foods, such as coffee, tea, cola, chocolate, etc; 4.Heavy alcohol users who have a drinking more than 28 standard units per week in the 1 month before screening. One standard unit contains 17.5mL or 14g of pure alcohol. The alcohol content of different varieties of alcohol is indicated by volume ratio, and the daily drinking amount is equivalent to 108mL of 52° white wine or 1400mL of 4° beer. Smokers with averaged >=5 cigarettes per day in the 3 months prior to screening. Those could not smoke or abstain from alcohol during the trial period; Or have alcohol breath test results >0.0mg/100mL; 5.People who are allergic to polyprezine, carnosine and zinc salts, or to two or more drugs (or foods); 6.Those who participated in other clinical trials and took study drugs within 3 months before screening; 7.Blood donation or blood loss >= 400mL (except physiological blood loss in women) within 3 months prior to screening, or who plan to donate blood or blood components during the study period or within 3 months after the end of the study; 8.Individuals who would not comply with the unified diet (such as intolerance to standard meals, etc.); 9.Any abnormality of clinically significant physical examination, vital signs, electrocardiogram or clinical laboratory measurement results at the time of screening; 10.Those with a positive test result, such as human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody or treponema pallidum antibody; 11.A history of drug abuse, drug dependence, or positive urine screening for drug abuse; 12.A history of fainting needles and fainting blood or can not tolerate venous puncture blood collection and known severe bleeding tendency; 13.Pregnant or lactating women, female subjects with unprotected sex in 2 weeks before screening, or female subjects with a positive pregnancy test; The subject (or his or her partner) plans to have a child or donate sperm or eggs throughout the trial period and within 3 months after the end of the study; Those who do not want to use one or more physical contraceptives during the trial period and for 3 months after the end of the study; 14.Subjects with poor compliance or who were considered unsuitable for enrollment by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting test PK (AUC0-8, AUC0-t, Cmax);Postprandial test PK (AUC0-8, AUC0-t, Cmax); | — |
Countries
China
Contacts
Public ContactShuang Li
Henan Infectious Disease Hospital
Outcome results
None listed