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

Study Overview
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Brief Summary
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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.

Official Title
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Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water

Conditions
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Healthy, Plasma Concentration of YM060

Intervention / Treatment
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* Drug: YM060


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orally-disintegrating (OD) tablet precedence group<br> | Drug: YM060<br>* oral, without water<br>* Other names: Irribow;|
| Experimental: conventional tablet precedence group<br> | Drug: YM060<br>* oral, without water<br>* Other names: Irribow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG |  | up to 24 hours after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM060, ramosetron, orally-disintegrating tablet, OD tablet, bioequivalence