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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:
Females must have a negative serum pregnancy test during screening confirmed by a negative urine pregnancy screen at the baseline visit. Women of childbearing potential must agree to continuously use a medically acceptable method of birth control during the course of the study. Acceptable birth control methods are hormonal contraceptives, intrauterine devices or double barrier method (a combination of condom plus contraceptive foam).
Postmenopausal females will be eligible to participate if their last normal menses was at least one (1) year prior to study entry.
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:
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 |