healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female Chinese healthy volunteers from Han population aged 18 to 45 years old; 2. Helicobacter pylori negative; 3. body mass index between 19-24 kg/m2; 4. Signed informed consent; 5. Physical examination and lab tests normal.
Exclusion criteria
Exclusion criteria: 1. With a history of severe diseases within 2 weeks and received drugs which influence liver P450 enzymes; 2. With severe cardiovascular, respiratory, renal, liver and gastrointestinal diseases; 3. Pregnant or breast-feeding women; 4. Concomintant intake of drugs which influence P450 enzymes or gastric acidity; 5. With a history of attendance in any other trial within 12 weeks; 6. With alcoholism or drug abuse; 7. With a history of allergy to the study drugs or severe allergy diseases; 8. Smokers or other nicotine takers; 9. Designers or executive peoples of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean intragastric pH values on day 1;percentages of time with intragastric pH>4 and pH>6 on day 1 and 5; | — |
Secondary
| Measure | Time frame |
|---|---|
| mean and median pH on day 1 and 5, mean ph value each hour, percentages of time with intragastric pH; | — |
Countries
China