A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2011
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedJuly 13, 2011
July 1, 2011
1 month
July 11, 2011
July 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG
up to 24 hours after administration
Study Arms (2)
orally-disintegrating (OD) tablet precedence group
EXPERIMENTALconventional tablet precedence group
EXPERIMENTALInterventions
oral, without water
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Japan
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 13, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
July 13, 2011
Record last verified: 2011-07