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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer; Pharmacokinetics of YM150

Treatments: Drug: YM150

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125657

150-CL-046

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

formualation-A to -B sequence group

Experimental group

Treatment:

Drug: YM150

formulation-B to -A sequence group

Experimental group

Treatment:

Drug: YM150