Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers

Pfizer

Status: Completed

Conditions: Healthy

Treatments: Drug: [S,S]-Reboxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444548

A6061028

Details and patient eligibility

About

[S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology

Enrollment: 12 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female subjects, aged 18-65 years.
• Subjects must be non-pregnant and non-lactating, and be either post menopausal (greater than 1 year without menses), surgically sterilized, or using another acceptable form of contraception.
• Subjects of child bearing potential must have confirmed negative pregnancy tests at screening and prior to commencing all study periods.

Exclusion criteria

• Evidence or history of clinically significant disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).
• Subjects with any clinically significant abnormality following review of laboratory data, urinalysis and physical examination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind