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| Name | Class |
|---|---|
| EPS Corporation | OTHER |
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The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C13-CAC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium (13C)Carbonate | Drug | Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 13CO2 concentration in expired air | 13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air | 5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration |
| 24-hour gastric pH | Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration | from completion of pre-study examination to before C13-CAC adminitration |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastric pH holding time ratio | pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring | from completion of pre-study examination to before C13-CAC adminitration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimiyoshi Sudoh | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPHAC Hospital | Osaka | Osaka | 532-0003 | Japan |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |