A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in healthy female volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedMarch 18, 2015
August 1, 2014
August 21, 2014
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the plasma concentration versus time curve (AUC)
0-4 hours
Peak Plasma Concentration (Cmax)
0-4 hours
Study Arms (2)
RGB-10
EXPERIMENTALForsteo
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy adult female subjects
- years of age (inclusive)
- BMI must be between 18.5 and 27 kg/m2 (inclusive)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion (UK)
Belfast, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2014
First Posted
August 22, 2014
Primary Completion
January 1, 2015
Last Updated
March 18, 2015
Record last verified: 2014-08