Duodenal Ulcer
Conditions
Interventions
Group A:Trial 1, period1: IIaprazol racemic 10mg (reference tablet, 5mg/TabletX2), orally taken by male subjects
Group B:Trial 1, period1: IIaprazol racemic 10mg (investigational agent, 10mg/Tablet*1), orally taken by male subjects
Group C:Trial 1, period1: IIaprazol racemic 10mg (reference tablet, 5mg/Tablet*2), orally taken by female subjects
Group D:Trial 1, period2: IIaprazol racemic 10mg (investigational agent, 10mg/Tablet*1), orally taken by male subjects
Group E:Trial 1, period 2: IIaprazol racemic 10mg (reference tablet, 5mg/Tablet*2), orally taken by male subjects
Group F:Trial 2: Total 3 periods, 3 crossovers and 2 elution periods. All participants orally taken clarithromycin, IIaprazol, larithromycin+llaprazol+amoxicillin resp in periods.
Group G:Trial3:IIaprazol 30mg orally taken once daily for 2 days by male subjects
Sponsors
Institute of Clinical Pharmacology,Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy men or women,aged between 19~45y,and the aged difference among the subjects is no more than 10y in one trial; 2. Weight over than 50kg,and BMI between 19 and 23 kg/m2; 3. Without gastrointestinal tracts diseases, liver or severely kidney injury and laboratory and physical inspection abnormal; 4. All subjects given the written informed consent; 5. Take no medicine drugs in last two weeks before trials.
Exclusion criteria
Exclusion criteria: 1. With the supersensitive history on drugs, and supersensitive with IIaprazol or its active compoent; 2. With arrhythmia,bronchusa and cardiovascular; disease,diabetes,hyperthyrea and other diseases can interfere on the results; 3. With the servious bleeding factors that can affect blood drawn; 4. With gastrointestinal tracts diseases, liver or severely kidney injury; 5. Participated other clinical trails in last three months, or taken any other drugs in last two weeks; 6. Subjects donated or lost blood in last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolite of IIaprazole;Blood drug concentration of IIaprazole and clarith;Blood drug concentration of llaprazole and IIapraz; | — |
Countries
China
Contacts
Public ContactHonghao Zhou
Outcome results
None listed