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Clinical trial

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.

NCT01260805 is registered in ClinicalTrials.gov with Pfizer as lead sponsor.

NCT NCT01260805
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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Pfizer
Phase
Phase 1
Overall status
Completed
Start date
September 30, 2010
Completion date
October 31, 2010
Enrollment
32 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalence, ethinylestradiol, gestodene, harmonet