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NCT00965978 Clinical Trial

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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00965978
Other study ID # 529-CL-027
Secondary ID
Status Completed
Phase Phase 1
First received August 25, 2009
Last updated October 1, 2009
Start date July 2009
Est. completion date September 2009

Study information
Verified date October 2009
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 81 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-5920 / YM529
oral

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Ono Pharma USA Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameter of ONO-5920/YM529 For 48 hours No
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