Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) and Dienogest (DNG) after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 2 mg Estradiol Valerate,3 mg Dienogest.Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg Estradiol Valerate, 3 mg Dienogest and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
43
Oral, single dose, 2 mg EV + 3 mg DNG + 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
Oral, single dose, 2 mg EV + 3 mg DNG washout phase between treatments: at least 7 days
Oral, single dose, 0.451 mg levomefolate calcium washout phase between treatments: at least 7 days
Unnamed facility
Neu-Ulm, Bavaria, Germany
AUC
Area under the concentration vs time curve from zero to infinity for DNG
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
Cmax
Maximum drug concentration for DNG and for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
AUC(0-tlast)
AUC from time 0 to the last data point above the lower limit of quantitation for E1, E2, E1S, and L-5-methyl-THF (baseline corrected and uncorrected)
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
tmax
Time to reach maximum drug concentration in plasma for DNG and E1, E2, E1S, and L-5-methyl-THF (baseline uncorrected)
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
t½
Half-life associated with the terminal slope for DNG and E1, E2, E1S, and L-5-methyl-THF
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
λz
Apparent terminal rate constant(estimates only) for DNG and E1, E2, E1S, and L-5-methyl-THF
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
AUC(0-tlast)
AUC from time 0 to the last data point above the lower limit of quantitation for DNG
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
AUC
Area under the concentration vs time curve from zero to infinity E1, E2, E1S, and L-5-methyl-THF (baseline corrected)
Time frame: Pre-dose and up to 72 hr post-dose for the treatments A and B and up to 12 hr post dose for the treatment C
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