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

This study has been completed.
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00965978
First received: August 25, 2009
Last updated: October 1, 2009
Last verified: October 2009
  Purpose
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.

Condition Intervention Phase
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases Drug: ONO-5920 / YM529 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic parameter of ONO-5920/YM529 [ Time Frame: For 48 hours ]

Enrollment: 48
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose group
Receives low dose of ONO-5920/YM529 with and without food
Drug: ONO-5920 / YM529
oral
Other Name: Minodronic Acid
Experimental: High dose group
Receives high dose of ONO-5920/YM529 with and without food
Drug: ONO-5920 / YM529
oral
Other Name: Minodronic Acid

  Eligibility

Ages Eligible for Study:   45 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965978

Locations
Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Ono Pharma USA Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00965978     History of Changes
Other Study ID Numbers: 529-CL-027
Study First Received: August 25, 2009
Last Updated: October 1, 2009

Keywords provided by Astellas Pharma Inc:
ONO-5920
YM529
Minodronic Acid
Food Effect

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Musculoskeletal Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 19, 2017