Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
Condition: Postmenopausal Symptoms
Intervention: Brisdelle (paroxetine mesylate)
Intervention description: All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
Intervention MeSH terms: Paroxetine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menopause; Hot flashes; Vasomotor symptoms; Climacteric symptoms; perimenopause; Mesafem; Brisdelle; Low-Dose Mesylate salt of Paroxetine (LDMP)

Summary:

      The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and
      elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate)
      Capsules 7.5 mg when given as a single dose and multiple doses.
    

Eligibility criteria:

        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.