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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00965978

Enrollment

Registered

2009-08-26

Start date

2009-07-31

Completion date

2009-09-30

Last updated

2009-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, Osteoporosis, Osteoporosis, Postmenopausal

Keywords

ONO-5920, YM529, Minodronic Acid, Food Effect

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.

Interventions

DRUGONO-5920 / YM529

oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 81 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameter of ONO-5920/YM529	For 48 hours

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026