NCT01260805

A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers.

A Phase I, Open Label, Randomized, Two-Way Crossover, Single Dose Study To Determine The Bioequivalence Of Ethinylestradiol + Gestodene - Harmonet 0,02mg + 0,075mg (Laboratórios Pfizer Ltda.) In The Sugar Coated Tablets Form, Versus Femiane® 0,02mg + 0,075mg (Schering Do Brasil Química E Farmacêutica Ltda.), In The Sugar Coated Tablets Form, Under Fasted Conditions In Female And Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under fasting conditions.

Detailed description

Bioequivalence Study

Conditions

• Bioequivalence
• Ethinylestradiol
• Gestodene
• Harmonet

Interventions

Type	Name	Description
DRUG	Reference Drug	Femiane® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose
DRUG	Test Drug	Harmonet® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-12-15
• Last updated: 2011-02-21

Locations

1 site across 1 country: Brazil