Conditions: Postmenopausal Symptoms
Keywords: Menopause Hot flashes Vasomotor symptoms Climacteric symptoms perimenopause Mesafem Brisdelle Low-Dose Mesylate salt of Paroxetine (LDMP)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: yes

Brief 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.

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

Arms:
arm 1: Brisdelle (paroxetine mesylate) Capsules taken orally with 240 mL of water for 20 days.

Interventions: intervention 1: Brisdelle (paroxetine mesylate)
Intervention descriptions: intervention 1: 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.

Protocol document: