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| Name | Class |
|---|---|
| Dong-A Pharmaceutical Co., Ltd. | INDUSTRY |
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DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These plants have been used in oriental traditional medicine for the treatment of gastrointestinal maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in functional dyspepsia patients and proved to have comparable safety and efficacy. However, its' exact effect on the gastrointestinal motility has not been completely elucidated. This study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-9701 and placebo | Other | Administer DA-9701 for 1week and assess the study outcomes. After 1 week of washout period, administer placebo for 1week and assess the outcomes again. |
|
| Placebo and DA-9701 | Other | Administer placebo for 1 week and study the outcome parameters. After 1 week of washout, administer DA-9701 for 1 week and assess the outcome parameters again. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-9701 and placebo | Drug | Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo. |
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| Measure | Description | Time Frame |
|---|---|---|
| Study the effects of DA-9701 on GI motility in healthy adult volunteers | Study the effects of DA-9701 on gastrointestinal motility in healthy adult volunteers | 3weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the effects of DA-9701 by Scintigraphic transit measurement | Examine the effects of DA-9701 by Scintigraphic transit measurement | 3weeks |
| Examine the effects of DA-9701 by EGG/Drink test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myong Ki Baeg, MD | CU Korea, Seoul St Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St Mary's hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C533973 | DA-9701 |
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| Placebo and DA-9701 | Drug | Administer placebo 1 tablet t.i.d for 1 week. After 1 week of washout, crossover to 30mg of DA-9701 t.i.d. for 1 week. |
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Examine the effects of DA-9701 by EGG/Drink test
| 3weeks |
| Examine the effects of DA-9701 by SPECT | Examine the effects of DA-9701 by SPECT | 3weeks |