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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis, Postmenopausal

Age range

45 year–81 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-5920 / YM529

Drug

oral

Other names: Minodronic Acid

Primary outcomes

Pharmacokinetic parameter of ONO-5920/YM529

Time frame: For 48 hours

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

Ono Pharma USA Inc

Registry information

Official study title

A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Aug 26, 2009
Registry last updated: Oct 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed