Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.

Official Title
-----------------
A Double-blind, Randomized, Two-way, Cross-over Study for Evaluating Motilitone on Gastric Motor Function in Healthy Volunteers

Conditions
-----------------
Healthy Female and Male

Intervention / Treatment
-----------------
* Drug: Motilitone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no gastrointestinal symptoms no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy written informed consent Exclusion Criteria: pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception history of abdominal surgery that may influence gastrointestinal motility gastrointestinal hemorrhage, mechanical ileus, enterobrosis irritable bowel syndrome, inflammatory bowel disease severe disturbance of liver, kidney, heart,lung,blood and endocrine psychoneurosis, alcoholism, drug dependence medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Motilitone<br>take motilitone 30mg three times daily for the first week After 7 day wash-out period, take placebo three times daily for the second week | Drug: Motilitone<br> <br> |
| Other: Placebo<br>take placebo three times daily for the first week After 7 day wash-out period, take motilitone 30mg three times daily for the second week | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric fuction of Motilitone | gastric emptying time on day 4 by scintigraphic imaging | 3 weeks | 
| gastric function of Motilitone | fasting and postprandial gastric volume on day 7 by single photon emission computed tomography | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events of Motilitone |  | 3 weeks | 
| small bowel function of Motilitone | small bowel transit time on day 4 by scintigraphic transit measurement | 3 weeks | 
| Colon function of Motilitone | colon transit time on day 4 and 7 by KUB | 3 weeks |