- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01125657
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
May 24, 2010 updated by: Astellas Pharma Inc
Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kyushu, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Body weight: ≥50.0 kg, <80.0 kg
- BMI: ≥17.6, <26.4
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests
Exclusion Criteria:
- Received any investigational drugs within 120 days before the study
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
- Received medication within 7 days before the study
- A deviation from the assessment criteria of physical examinations or laboratory tests
- A deviation from the normal reference range of coagulation test [PT (INR) or aPTT]
- History of drug allergies
- Upper gastrointestinal disease within 7 days before the study
- Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
- Concurrent or previous malignant tumor
- Previous treatment with YM150
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: formualation-A to -B sequence group
|
oral
|
Experimental: formulation-B to -A sequence group
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration of YM150 and its metabolites measured by blood sample
Time Frame: for 3 days after drug administration
|
for 3 days after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests
Time Frame: or 3 days after drug administration
|
or 3 days after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
May 17, 2010
First Submitted That Met QC Criteria
May 17, 2010
First Posted (Estimate)
May 18, 2010
Study Record Updates
Last Update Posted (Estimate)
May 25, 2010
Last Update Submitted That Met QC Criteria
May 24, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150-CL-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteer
-
BiogenRecruiting
-
International Bio serviceNot yet recruiting
-
International Bio serviceNot yet recruiting
-
International Bio serviceNot yet recruiting
-
Angion Biomedica CorpQuotient SciencesNot yet recruitingHealthy VolunteerUnited States
-
University Hospital, ToursRecruitingNeurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults (PROSCEA)Healthy VolunteerFrance
-
BiogenActive, not recruiting
-
TeneoFour Inc.Novotech (Australia) Pty LimitedCompletedHealthy VolunteerAustralia
-
Spero TherapeuticsCompleted
-
AbbVieCompletedHealthy VolunteerUnited States
Clinical Trials on YM150
-
Astellas Pharma IncCompletedAtrial FibrillationGermany, Korea, Republic of, Australia, Poland, United Kingdom, Japan, South Africa, Russian Federation, Austria, Estonia, Thailand, Bulgaria, France, Spain, Ukraine, India, Israel, Hungary, Slovakia, Malaysia, Philippines, Czech... and more
-
Astellas Pharma IncCompletedArthroplasty, Replacement, KneeUnited States, Canada
-
Astellas Pharma IncCompletedAtrial FibrillationTaiwan, Japan, Korea, Republic of, New Zealand, Singapore, South Africa, Thailand, Australia, Hong Kong, Malaysia
-
Astellas Pharma IncCompletedThromboembolismSingapore, Indonesia, Japan, Korea, Republic of, Malaysia, Philippines, Taiwan, Thailand
-
Astellas Pharma Europe B.V.CompletedVenous Thromboembolism | Arthroplasty, Replacement, HipDenmark, Spain, United States, Austria, Colombia, Russian Federation, India, Italy, United Kingdom, Germany, Hungary, Estonia, Romania, South Africa, Israel, Poland, Sweden, Canada, Australia, Lithuania, Ukraine, Latvia, Finland, Brazil, Slovak... and more
-
Astellas Pharma IncCompletedVenous ThromboembolismJapan, Taiwan, Thailand
-
Astellas Pharma IncCompletedVenous ThromboembolismJapan, Korea, Republic of, Taiwan, Thailand
-
Astellas Pharma IncCompletedVenous ThromboembolismJapan
-
Astellas Pharma IncCompletedVenous ThromboembolismJapan
-
Astellas Pharma Europe B.V.CompletedAcute Coronary SyndromePoland, Colombia, Germany, Korea, Republic of, South Africa, Czech Republic, Netherlands, Hungary, Russian Federation, Mexico, Romania, Argentina, Ukraine, Denmark, Slovakia, Belgium, India, Brazil, Australia, Canada, France