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

Phase 1 Completed 24 enrolled Noven Therapeutics

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2011-07
Primary completion: 2011-08
Completion: 2011-08

Publications

Cristina Castelli M, Bhaskar S, Lippman J. Pharmacokinetic properties of once-daily oral low-dose mesylate salt of paroxetine (LDMP 7.5 mg) following single and multiple doses in healthy postmenopausal women. Clin Ther. 2013 Jun;35(6):862-9. doi: 10.1016/j.clinthera.2013.05.001.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paroxetine	Small molecule	7.5 mg	Oral

Indications

No indication recorded.