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A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01394653
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.

Condition or disease Intervention/treatment Phase
Healthy Plasma Concentration of YM060 Drug: YM060 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion With Water -
Study Start Date : July 2011
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: orally-disintegrating (OD) tablet precedence group Drug: YM060
oral, with water
Other Names:
  • ramosetron
  • Irribow
Experimental: conventional tablet precedence group Drug: YM060
oral, with water
Other Names:
  • ramosetron
  • Irribow


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394653


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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01394653     History of Changes
Other Study ID Numbers: 060-CL-209
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Astellas Pharma Inc:
YM060
ramosetron
orally-disintegrating tablet
OD tablet
bioequivalence

Additional relevant MeSH terms:
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action