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| Sponsor: | Somerset Pharmaceuticals |
|---|---|
| Information provided by: | Somerset Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00532116 |
Purpose
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: | Control: Active Control Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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
|
Eligibility| 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:
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:
Contacts and Locations
More Information
| 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 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 |