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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: July 11, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
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.

Condition Intervention Phase
Plasma Concentration of YM060
Drug: YM060
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Area under the curve of YM060 plasma concentration -time curve [ Time Frame: up to 24 hours after administration ]
  • Maximal concentration of YM060 plasma concentration [ Time Frame: up to 24 hours after administration ]

Secondary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG [ Time Frame: up to 24 hours after administration ]

Enrollment: 36
Study Start Date: April 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: orally-disintegrating (OD) tablet precedence group Drug: YM060
oral, without water
Other Names:
  • ramosetron
  • Irribow
Experimental: conventional tablet precedence group Drug: YM060
oral, without water
Other Names:
  • ramosetron
  • Irribow


Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01392794

Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT01392794     History of Changes
Other Study ID Numbers: 060-CL-208
Study First Received: July 11, 2011
Last Updated: July 11, 2011

Keywords provided by Astellas Pharma Inc:
orally-disintegrating tablet
OD tablet

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017