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

Healthy Volunteer Clinical Trial

Official title:

Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125657
• Other study ID #: 150-CL-046
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2010
• Last updated: May 24, 2010
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: May 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer
• Pharmacokinetics of YM150

Intervention

Drug:
• YM150
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of YM150 and its metabolites measured by blood sample		for 3 days after drug administration	No
Secondary	Safety assessed by AEs, vital signs, 12-lead ECG and lab tests		or 3 days after drug administration	No