Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: DA-9701 and placebo
* Drug: Placebo and DA-9701


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults of either sex, at least 20 years of age Having no abdominal discomfort or pain No diseases diagnosed by screening gastroduodenoscopy Having given voluntary written consent Exclusion Criteria: Currently participating or having participated in another drug trial within four weeks of trial start. Women of childbearing age who are either pregnant, breast-feeding or not under proper contraceptive methods. A history of surgery which may affect gastrointestinal motility. Subjects with gastrointestinal bleeding, mechanical obstruction or perforation. Subjects with irritable bowel syndrome or inflammatory bowel disease. Subjects with serious conditions involving the liver, kidneys, heart, lung or endocrinology system. Psychiatric disease patients, substance abuse subjects such as alcohol or drugs. Subjects who have taken drugs that may affect the study outcome such as antibiotics, corticosteroids or NSAIDS within 1 month or motility agents, H2 receptor blockers, proton pump inhibitors, anticholinergics, erythromycin or antipsychotics within 2 weeks. Other reasons that the investigator considers valid.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DA-9701 and placebo<br>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. | Drug: DA-9701 and placebo<br>* Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.<br>* Other names: DA-9701(motilitone);|
| Other: Placebo and DA-9701<br>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. | Drug: Placebo and DA-9701<br>* 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.<br>* Other names: DA-9701(motilitone);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |