Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application
Condition: Healthy Volunteers
Intervention: Afolia; US Gonal-f®
Intervention description: During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:
Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.
Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27; During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:
Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.
Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Afolia; Follitropin

Summary:

      Comparative PK study after single SC application of Afolia and the reference product (US
      Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference
      product for the area under the curve (AUC) of Afolia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy female volunteers aged 18 to 42 years (inclusive) with a Body mass index of
             18.0 to 32.0 kg/m2 (inclusive)

          2. 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

          3. 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

          4. Subjects with a regular menstruation cycle (25 to 34 days) before initiation of oral
             contraception

          5. Subjects with both ovaries

          6. Subjects who are negative for drugs of abuse and alcohol tests at screening and each
             admission

          7. Subjects who are healthy as determined by pre study medical history, physical
             examination and 12-Lead electrocardiogram (ECG)

          8. Subjects whose clinical laboratory test results are not clinically relevant and are
             acceptable to the investigator

          9. Subjects who are able and willing to give written informed consent

        Exclusion Criteria:

          1. Subjects who do not conform to the above inclusion criteria

          2. Subjects with polycystic ovary syndrome

          3. Subjects with developing follicles or solid ovarian cysts >2 cm or complex cysts
             regardless of size

          4. Subjects with a history of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome)

          5. Subjects with impaired thyroid function (treated or untreated)

          6. Subjects with a history of malignant disease

          7. Subjects with aspartate aminotransferase and/or alanine aminotransferase >2 x upper
             limit of normal reference range

          8. Subjects with other clinically relevant findings (ECG, blood pressure, physical,
             laboratory examination)

          9. Subjects with a smoking history of more than 5 cigarettes per day

         10. Subjects with evidence of abuse of drugs or alcoholic beverages

         11. 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

         12. Subjects who have participated in a clinical trial within the 3 months prior to this
             study

         13. Subjects who are unlikely to co-operate with the requirements of the study

         14. Subjects with symptoms of a clinically relevant illness during the 3 weeks prior to
             study day -1

         15. Subjects who are pregnant, lactating or attempting to become pregnant

         16. 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

         17. Subjects who are vegans or have medical dietary restrictions

         18. Subjects who cannot communicate reliably with the investigator