Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT01392794
Eligibility Criteria:
Inclusion Criteria:
* healthy assessed by the principal investigator or sub-investigators
* non-smoking or stop smoking at least 90 days before the study
* body weight: over 50.0kg and less than 80.0kg
* body mass index (BMI): over 17.6 and less than 26.4
Exclusion Criteria:
* participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
* donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
* received any drugs within 7 days before the study or going to receive any drugs
* deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
* deviance from normal range in lab-tests
* history of drug allergy
* history or current diagnosis of stomach, small intestine or large intestine diseases
* history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* history or current diagnosis of colitis ischemic
* history or current diagnosis of hepatic diseases
* history or current diagnosis of cardiovascular diseases
* history or current diagnosis of respiratory diseases
* history or current diagnosis of malignant tumor
* received ramosetron tablet
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
44 Years
Study:
NCT01392794
Study Brief:
Protocol Section:
NCT01392794