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

Phase 1

Completed

• Conditions: Healthy; Plasma Concentration of YM060
• Interventions: Drug: YM060

• Registration Number: NCT01392794
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Last Update Submitted: 2011-07-11
• Study First Posted: 2011-07-13
• Last Update Posted: 2011-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
orally-disintegrating (OD) tablet precedence group	YM060	-
conventional tablet precedence group	YM060	-

Primary Outcome Measures

Name	Time	Method
Area under the curve of YM060 plasma concentration -time curve	up to 24 hours after administration
Maximal concentration of YM060 plasma concentration	up to 24 hours after administration

Secondary Outcome Measures

Name	Time	Method
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG	up to 24 hours after administration