Bioavailability Study With Oral Single Dose Administration of Ethinylestradiol and Dienogest

Summary

* Characterisation of relative bioavailability of Diena (Test) in comparison to Valette® (Reference) after single dose administration under fasting conditions * Assessment of bioequivalence of Test vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and dienogest (DNG) * Descriptive characterisation of safety and tolerability of the investigational products in the study population

Timeline

Start

2010-01

Primary completion

2010-02

Completion

2010-02

Drugs

Indications

No indication recorded.