Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women

This study is for research only and is not designed to treat a medical condition.

Inclusion Criteria:

Subjects who are healthy postmenopausal, non-smoking women of any race and ≥40 years of
age at screening.

Exclusion Criteria:

Subjects who have a recent history or presence of glaucoma, migraines, cardiovascular,
hepato-biliary, renal, gastrointestinal, neurologic, psychiatric, dermatologic, pulmonary,
cerebrovascular, endocrine, hematologic, thromboembolic, immunologic disease or any other
disorder which requires physician care; subjects who have existing medical conditions
which might interfere with absorption, distribution, metabolism, or excretion of study
medication; history of self-injurious behavior; history of clinical diagnosis of
depression; or treatment for depression; history of clinical diagnosis of border-line
personality disorder; presence of any of the following psychiatric disorders within the
timeframes specified: Major Depressive Disorder-Lifetime; Dysthymia-Past 2 Years; Bipolar
Disorder-Lifetime; Panic Disorder-Lifetime; Agoraphobia-Past Month; Social Phobia-Past
Month; Obsessive Compulsive Disorder-Past Month; Generalized Anxiety-Lifetime; Psychotic
Disorders-Lifetime; Anorexia Nervosa-Past 10 Years; Bulimia-Past 10 Years;
Suicidality/Suicide Ideation-Lifetime; Post Traumatic Stress Disorder-Lifetime.

Subjects with a history of seizures; sitting blood pressure (BP) < 90/50 or > 150/90 mmHg;
sitting heart rate (HR) < 45 or > 90 beats/min; clinical laboratory test results outside
of the normal range for the laboratory conducting the test; positive urine pregnancy test
at Screening or Day 0; subjects who have a history of sensitivity to active and/or
inactive ingredients in Brisdelle (paroxetine mesylate) Capsules 7.5 mg; subjects who have
a history of significant allergies; subjects who have a present or past history of
narcotic addiction, drug abuse, or alcoholism; subjects who have smoked or used tobacco
during the last 6 months; subjects who have donated one or more pints of blood within 30
days prior to treatment administration; subjects who have symptoms of any significant
acute illnesses at the screening visit; subjects who used any investigational drug within
30 days prior to treatment administration; subjects who took any substances known to be
Cytochrome P450 2D6 (CYP2D6) inhibitors within 14 days of study start and throughout the
entire study; subjects who used any prescription medications within 14 days of the
screening visit; subjects who used St John's Wort within 14 days of the screening visit;
subjects who used any over the counter preparations including herbal or nutritional
supplements and multivitamins within 10 days prior to receiving the first study treatment;
subjects who have consumed foods or beverages containing caffeine/xanthine or alcohol;
subjects who have a positive screen for hepatitis B surface antigen (HBsAg) or hepatitis C
antibody; subjects who have a positive screen for the Human Immunodeficiency Virus (HIV)
antibody; subjects who have a positive urine drug screen; subjects who have any clinically
significant illness within 90 days prior to receiving the first dose of study medication.