Status:
COMPLETED
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Ono Pharma USA Inc
Conditions:
Osteoporosis
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
45-81 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- Receives investigational drug within 120 day before the study
- Blood donation before the study
- With abnormal laboratory values
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00965978
Start Date
July 1 2009
End Date
September 1 2009
Last Update
October 5 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kantou, Japan