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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
History of Changes
  Purpose

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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
oral
Experimental: formulation-B to -A sequence group Drug: YM150
oral

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125657

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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01125657     History of Changes
Other Study ID Numbers: 150-CL-046
Study First Received: May 17, 2010
Last Updated: May 24, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM150
bioequivalence study

ClinicalTrials.gov processed this record on May 23, 2013