The aims of this study were to characterise relative bioavailability of Diena (Test) in comparison to Valette® (Reference) after single dose administration under fasting conditions and to assess 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 maximal concentration Cmax obtained for ethinylestradiol (EE) and dienogest (DNG). Furthermore, a descriptive characterisation of safety and tolerability of the investigational products in the study population was performed.
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