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

NCT01125657 | Completed Phase 1

• 1 other identifier: 150-CL-046
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer; Pharmacokinetics of YM150

Keywords

YM150; bioequivalence study

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of YM150 and its metabolites measured by blood sample

  for 3 days after drug administration

Secondary Outcomes (1)

• Safety assessed by AEs, vital signs, 12-lead ECG and lab tests

  or 3 days after drug administration

Study Arms (2)

formualation-A to -B sequence group

EXPERIMENTAL

Drug: YM150

formulation-B to -A sequence group

EXPERIMENTAL

Drug: YM150

Interventions

YM150 DRUG

oral

formualation-A to -B sequence group; formulation-B to -A sequence group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 25, 2010

Record last verified: 2010-05

Locations

JP (1)