Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the reference product (Gonal-f®). Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
32
Area under the serum concentration curve (AUC) of FSH
Time frame: 0 -192h after FSH injection
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