NCT01829919

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

Evaluation of Pharmacokinetics of Paroxetine Following Single and Repeat Oral Administration of Mesafem (7.5 mg Paroxetine Mesylate) Capsules in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postmenopausal Symptoms

Interventions

Type	Name	Description
DRUG	Brisdelle (paroxetine mesylate)	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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2013-04-11
• Last updated: 2015-10-15
• Results posted: 2014-02-24

Locations

1 site across 1 country: United States