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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01125657
First received: May 17, 2010
Last updated: May 24, 2010
Last verified: May 2010

May 17, 2010
May 24, 2010
February 2010
March 2010   (final data collection date for primary outcome measure)
Plasma concentration of YM150 and its metabolites measured by blood sample [ Time Frame: for 3 days after drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01125657 on ClinicalTrials.gov Archive Site
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests [ Time Frame: or 3 days after drug administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Healthy Volunteer
  • Pharmacokinetics of YM150
Drug: YM150
oral
  • Experimental: formualation-A to -B sequence group
    Intervention: Drug: YM150
  • Experimental: formulation-B to -A sequence group
    Intervention: Drug: YM150
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01125657
150-CL-046
No
Director, Astellas Pharma, Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
May 2010

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