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Sponsored by: |
Somerset Pharmaceuticals |
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Information provided by: | Somerset Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00532116 |
Evaluate the effect of age on the PK of two different doses of EMSAM.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: EMSAM (Selegiline Transdermal System) 6mg Drug: EMSAM (Selegiline Transdermal System) 12mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetic Comparison of the 6mg/24hr and 12mg/24hr EMSAM (Selegiline Transdermal System) in Healthy Elderly and Non-Elderly Volunteers |
Enrollment: | 32 |
Study Start Date: | April 2007 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
EMSAM 6mg
|
Drug: EMSAM (Selegiline Transdermal System) 6mg
STS 6mg/24hr
|
B: Active Comparator
EMSAM (Selegiline Transdermal System) 12mg
|
Drug: EMSAM (Selegiline Transdermal System) 12mg
EMSAm 12mg/24Hr
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Presence of significant acute or chronic medical disorder that might complicate or interfere with MAO inhibitor therapy, such as:
Malignancy and/or chemotherapy within 1 year prior to screening, other than basal cell carcinoma.
Malignancies more than 1 year may not preclude participation and will be reviewed on a case-by-case basis by the Somerset Pharmaceuticals, Inc., medical monitor.
Use of any medication listed below within five half-lives prior to baseline. A longer period of time may be specifically noted for certain medications as indicated:
Study ID Numbers: | S9303-P0601 |
Study First Received: | September 18, 2007 |
Last Updated: | September 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00532116 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy Elderly Non Elderly Healthy Volunteers |
Selegiline Healthy Neuroprotective Agents |
Selegiline Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Monoamine Oxidase Inhibitors |
Antiparkinson Agents Enzyme Inhibitors Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |