Gastric acid related diseases
Conditions
Interventions
Group A:In the fasting state, single and multiple oral doses of the reference formulation 20mg firstly, then single and multiple oral doses of the test preparation 20mg, then single and multiple oral
Group B:In the fasting state, single and multiple oral doses of the test formulation 20mg firstly, then single and multiple oral doses of the reference preparation 20mg, then single and multiple oral
Sponsors
The first affiliated hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
22 Years to 29 Years
Inclusion criteria
Inclusion criteria: (1) Healthy subjects; (2) Subject is 18~40 years old and the age difference should less than 10 years in the same batch, the sexual portion is equal; (3) BMI in range of 19~25kg/m2 [BMI=weight (kg)/height 2(m2)]; (4) Subject is able to communicate with investigator well and comply with requires of study; (5) Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: (2) Blood donation in the last 1 month or intend to donate blood in the following 1 month; (3) Used any medicine in the last 2 weeks; (4) Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and nervous system, metabolic disturbance, etc (5) The general examination and blood pressure, heart rate and respiratory conditions are not qualified; (6) Physical examination found that there are any significant clinical symptoms; (7) Laboratory test (hematology, urine analysis, blood biochemistry, ECG examination and the four markers) results judged as Heart, liver and kidney dysfunction; (8) Women in gestation period and lactation period, and menstrual period; (9) Allergic constitution: the persons allergic to two or more medicines, food and pollen or ingredients of investigator produc; (10) Drug abusers, tobacco and alcohol addiction; (11) Unsuitable to participate in the trial considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCtn;Cmax;Tmax;t1/2z;Cl/F;Vz/F;AUCss;Css_min;Cavg;fluctuation%; | — |
Countries
China
Contacts
Public ContactJianzhong Shentu
Outcome results
None listed