Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application

Inclusion Criteria

• Healthy female volunteers aged 18 to 42 years (inclusive) with a Body mass index of 18.0 to 32.0 kg/m2 (inclusive)
• Subjects who have used oral contraceptives for at least 3 months before study entry and are prepared to stop taking oral contraception from screening and to use effective non-hormonal methods of birth control until completion of 1 menstrual cycle after the last dose administration
• Women of child bearing potential must agree to use effective non-hormonal contraception for birth control until completion of 1 menstrual cycle after the last dose administration
• Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral contraception
• Subjects with both ovaries
• Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission
• Subjects who are healthy as determined by pre study medical history, physical examination and 12-Lead electrocardiogram (ECG)
• Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the investigator
• Subjects who are able and willing to give written informed consent

Exclusion Criteria

• Subjects who do not conform to the above inclusion criteria
• Subjects with polycystic ovary syndrome
• Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts regardless of size
• Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome)
• Subjects with impaired thyroid function (treated or untreated)
• Subjects with a history of malignant disease
• Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper limit of normal reference range
• Subjects with other clinically relevant findings (ECG, blood pressure, physical, laboratory examination)
• Subjects with a smoking history of more than 5 cigarettes per day
• Subjects with evidence of abuse of drugs or alcoholic beverages
• Subjects with a positive screen for hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus 1/2
• Subjects who have participated in a clinical trial within the 3 months prior to this study
• Subjects who are unlikely to co-operate with the requirements of the study
• Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to study day -1
• Subjects who are pregnant, lactating or attempting to become pregnant
• Subjects with any medical condition (including a known predisposition to porphyria) that, in the opinion of the investigator, could interfere with safety of the subject or interfere with the objectives of the study
• Subjects who are vegans or have medical dietary restrictions
• Subjects who cannot communicate reliably with the investigator