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The purpose of this study is to evaluate the safety and efficacy of the additional administration of scopolamine butylbromide, glucagon or NPO-11 following a single intragastric dose of NPO-11 during endoscopy in healthy adult men. The safety will be evaluated based on adverse events and adverse drug reactions (ADRs) observed with NPO-11 + scopolamine butylbromide or glucagon, and following additional administration of NPO-11. The efficacy will be evaluated based on changes in the frequency of gastric peristalsis classification after the initial dose and the additional dose, and on the presence or absence of gastric peristalsis at each evaluation point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N | Active Comparator |
| |
| B | Active Comparator |
| |
| G | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPO-11 | Drug | 20 mg butylscopolammonium bromide after administration of NPO-11 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| [Safety] (Evaluation by investigator or subinvestigator) Adverse events and ADRs observed between administration and 7 ± 3 days after administration | 7 ± 3 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| [Efficacy] (Central evaluation by independent evaluator) (1) Change in the frequency of gastric peristalsis classification (2) Presence or absence of gastric peristalsis at each evaluation point | each evaluation point |
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Inclusion Criteria:
Healthy adult male volunteers who meet all the following criteria will be enrolled in the study. Subjects have to provide written informed consent for voluntary participation in the study.
Exclusion Criteria:
Volunteers who meet any of the following criteria will be excluded from the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| NPO-11 |
| Drug |
NPO-11 after administration of NPO-11 |
|
| NPO-11 | Drug | 1 mg glucagons after administration of NPO-11 |
|