A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation

Phase 1

Completed

• Conditions: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases
• Interventions: Drug: ONO-5920 / YM529

• Registration Number: NCT00965978
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Post menopausal women (at least 2 years after menopause)
• Body weight: more than 40.0 Kg and less than 70.0 Kg
• BMI: more than 17.6 and less than 30.0

Exclusion Criteria

• Receives investigational drug within 120 day before the study
• Blood donation before the study
• With abnormal laboratory values

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low dose group	ONO-5920 / YM529	Receives low dose of ONO-5920/YM529 with and without food
High dose group	ONO-5920 / YM529	Receives high dose of ONO-5920/YM529 with and without food

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter of ONO-5920/YM529	For 48 hours