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

Astellas Pharma Inc48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoporosis Osteoporosis, Postmenopausal Bone Diseases

Interventions

ONO-5920 / YM529DRUG

oral

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 81 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Kantou, Japan

Outcomes

Primary Outcomes

Pharmacokinetic parameter of ONO-5920/YM529

Time frame: For 48 hours

Data from ClinicalTrials.gov

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