Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers

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

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.

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