This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
Unnamed facility
Neu-Ulm, Germany
Area under the Curve (0-t)
Time frame: Up to 72 hours after trial product administration
Cmax, maximum concentration
Time frame: Up to 72 hours after trial product administration
Time to maximum (tmax)
Time frame: Up to 72 hours after trial product administration
Area under the curve from time zero to infinity
Time frame: Up to 72 hours after trial product administration
Terminal half-life (t½)
Time frame: Up to 72 hours after trial product administration
Terminal rate constant
Time frame: Up to 72 hours after trial product administration
Incidence of adverse events (AEs)
Time frame: Week 8
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