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Sponsored by: |
Orion Corporation, Orion Pharma |
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Information provided by: | Orion Corporation, Orion Pharma |
ClinicalTrials.gov Identifier: | NCT00831077 |
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 in healthy volunteers.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: ORM-14540 Drug: ORM-12741 |
Phase 0 |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Pharmacokinetic Properties of ORM-14540 and ORM-12741 After Administration of a Microdose of 14C-Labelled Drug; An Open, Non-Randomised, Single Dose, Single Centre Study in Healthy Male Subjects |
Estimated Enrollment: | 6 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
14C-ORM-14540: Active Comparator |
Drug: ORM-14540
i.v.
|
14C-ORM-12741: Active Comparator |
Drug: ORM-12741
i.v.
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Virpi Mononen | +358 10 4261 | virpi.mononen@orionpharma.com |
Finland | |
CRST | Recruiting |
Turku, Finland |
Principal Investigator: | Juha Peltonen, MD | CRST |
Study Director: | Virpi Mononen | Orion Corporation, Orion Pharma |
Responsible Party: | Development ( Mononen/Clinical Study Manager ) |
Study ID Numbers: | 3101001 |
Study First Received: | January 27, 2009 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00831077 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
Healthy volunteers |
Healthy |