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A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: May 17, 2010
Last updated: May 24, 2010
Last verified: May 2010
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.

Condition Intervention Phase
Healthy Volunteer Pharmacokinetics of YM150 Drug: YM150 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Plasma concentration of YM150 and its metabolites measured by blood sample [ Time Frame: for 3 days after drug administration ]

Secondary Outcome Measures:
  • Safety assessed by AEs, vital signs, 12-lead ECG and lab tests [ Time Frame: or 3 days after drug administration ]

Enrollment: 44
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: formualation-A to -B sequence group Drug: YM150
Experimental: formulation-B to -A sequence group Drug: YM150


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01125657

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

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT01125657     History of Changes
Other Study ID Numbers: 150-CL-046
Study First Received: May 17, 2010
Last Updated: May 24, 2010

Keywords provided by Astellas Pharma Inc:
bioequivalence study

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on September 20, 2017