Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01392794
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
Sponsor:
Information provided by:
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE July 11, 2011
First Posted Date  ICMJE July 13, 2011
Last Update Posted Date July 13, 2011
Study Start Date  ICMJE April 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG [ Time Frame: up to 24 hours after administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
Official Title  ICMJE Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Healthy
  • Plasma Concentration of YM060
Intervention  ICMJE Drug: YM060
oral, without water
Other Names:
  • ramosetron
  • Irribow
Study Arms  ICMJE
  • Experimental: orally-disintegrating (OD) tablet precedence group
    Intervention: Drug: YM060
  • Experimental: conventional tablet precedence group
    Intervention: Drug: YM060
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2011)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01392794
Other Study ID Numbers  ICMJE 060-CL-208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Astellas Pharma, Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Use Central Contact Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP