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

Study Overview
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Brief Summary
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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®).

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AFOLIA
* Drug: Gonal-f


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFOLIA<br>225 IU sc | Drug: AFOLIA<br>* single sc injection, 225 IU<br>|
| Active Comparator: Gonal-f<br>225 IU sc | Drug: Gonal-f<br>* single sc injection, 225IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum concentration curve (AUC) of FSH |  | 0 -192h after FSH injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recombinant human follicle stimulating hormone, pharmacokinetics, bioequivalence