NCT01359163

A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects

An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.

Conditions

• Therapeutic Equivalency

Interventions

Type	Name	Description
DRUG	etynodiol diacetate	tablet, 0.5 mg, single dose
DRUG	etynodiol diacetate	tablet, 0.5 mg, single dose

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-05-24
• Last updated: 2012-04-04

Locations

1 site across 1 country: Singapore