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

October 1, 2009 updated by: Astellas Pharma Inc

A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose group
Receives low dose of ONO-5920/YM529 with and without food
Drug: ONO-5920 / YM529
oral
Other Names:
  • Minodronic Acid
Experimental: High dose group
Receives high dose of ONO-5920/YM529 with and without food
Drug: ONO-5920 / YM529
oral
Other Names:
  • Minodronic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameter of ONO-5920/YM529
Time Frame: For 48 hours
For 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Ono Pharma USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2009

Last Update Submitted That Met QC Criteria

October 1, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 529-CL-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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