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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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This study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying abnormal (delayed) gastric emptying rates in subjects.
Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10 subjects per group.
The subjects will first have their gastric emptying rates investigated by scintigraphy using the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for evaluation of the 13C-uracil GEBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13C-uracil and 99mTc sulfur colloid | Experimental | Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil. |
|
| 99mTc sulfur colloid | Experimental | Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13C-uracil | Drug | PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expired 13CO2 concentrations | Expired 13CO2 concentrations are obtained from breath test. The values will be calculated to Re(t)[B] semi-solid: remaining (%) of semi-solid test meal in stomach at t, t1/2[B] semi solid: half emptying time of semi-solid test meal , and tlag[B] semi-solid: lag time of semi-solid test meal. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of 13C-uracil and its major metabolites in plasma and urine | PK parameters of 13C-uracil and its major metabolites, DHU and UPA, including AUCt, AUC∞, Cmax, tmax, λz, and t1/2,z, will be calculated based on plasma and urine concentration for 13C-uracil and its metabolites, and expired 13CO2-excretion, which calculated based on expired 13CO2 concentrations | 6 hours |
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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 |
|---|---|---|---|---|---|---|
| Compass Research | Orlando | Florida | 32806 | United States | ||
| Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology |
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| ID | Term |
|---|---|
| C030406 | technetium Tc rhenium-sulfur colloid |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
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| 99mTc sulfur colloid | Drug | PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy. |
|
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| Lebanon |
| New Hampshire |
| 03756 |
| United States |