Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application

Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application. A Randomised, Open Label, Cross Over Study

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®).

Inclusion Criteria:

• Healthy female volunteers
• Age between 18-38 years
• Body mass index 17-29 kg/m2
• Woman of child bearing potential must agree to practice effective barrier methods for birth control
• Use of oral contraceptives for at least 3 months before study entry
• Regular menstruation cycle (25-34 days) before initiation of oral contraception
• Presence of both ovaries
• Normal findings in medical history and physical and gynaecological examination unless the investigator considers an abnormality to be clinically irrelevant for this study
• Signed informed consent

Exclusion Criteria:

• Polycystic ovary syndrome (PCOS)
• History of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome, OHSS)
• Impaired thyroid function (treated or untreated)
• History of malignant disease
• AST and/or ALAT > 2 x ULN
• Other clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
• Smoking habits of more than 5 cigarettes per day
• Abuse of alcoholic beverages and drugs
• Participation in a clinical trial within 3 weeks prior to the study
• Foreseen inability to attend to scheduled study visits
• Symptoms of a clinically relevant illness during 3 weeks prior the first study day
• Pregnancy or lactation period
• Any medical condition that, in the opinion of the investigator, would interfere with safety of the subject or interference of the objectives of the study