A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy

Plasma Concentration of YM060

Treatments

Drug: YM060

Study type

Interventional

Funder types

Industry

Identifiers

NCT01392794

060-CL-208

Details and patient eligibility

About

A study to compare time-course changes of plasma concentration of YM060 after intake of conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be administered without water.

Enrollment

36 patients

Sex

Male

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

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