The Safety and Pharmacokinetics of Primapur and Gonal-f
Condition: Area Under Curve; Pharmacokinetics; Absorption
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current phase I study was to establish bioequivalence, safety, and
      tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in
      comparison to that of reference follitropin alfa preparation (Gonal-F) in healthy young
      female volunteers.
    

Detailed description: 
      A Phase I, prospective, randomized, open-label, crossover, 2-period, two treatment, clinical
      study in healthy female volunteers.

      Objectives of the study:

        1. To evaluate the frequency and severity of adverse events (AE) following a single 300 IU
           subcutaneous injection of Primapur (IVFarma, LLC, Russia) and Gonal-F (Merck Serono
           S.p.A., Italy) to healthy volunteers.

        2. To determine the AUC0-t value of Primapur following a single 300 IU subcutaneous
           injection to healthy volunteers.

        3. To determine the T½ value of Primapur following a single 300 IU subcutaneous injection
           to healthy volunteers.

        4. To determine the Сmax value of Primapur following a single 300 IU subcutaneous injection
           to healthy volunteers.

        5. To determine the Tmax value of Primapur following a single 300 IU subcutaneous injection
           to healthy volunteers.

        6. To compare the obtained pharmacokinetic characteristics of Primapur and Gonal-F.
    

Intervention name(s): Follitropin alfa (Primapur); Follitropin alfa (Gonal-F)
Intervention type(s): Drug; Drug
Intervention description(s): During the crossover pharmacokinetic phase, after 42 days of combined oral contraceptive (ethinylestradiol and drospirenone) administration subjects with endogenous level of follicle stimulating hormone (FSH) less than 5 IU/l were randomly assigned to receive one of the following treatment sequences:
Sequence A: Single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Gonal-F.
Sequence B: Single subcutaneous injection of 300 IU US Gonal-F on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Primapur.; During the crossover pharmacokinetic phase, after 42 days of combined oral contraceptive (ethinylestradiol and drospirenone) administration subjects with endogenous level of follicle stimulating hormone (FSH) less than 5 IU/l were randomly assigned to receive one of the following treatment sequences:
Sequence A: Single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Gonal-F.
Sequence B: Single subcutaneous injection of 300 IU US Gonal-F on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Primapur.
Other intervention name(s): Follitropin alpha; Follitropin; Follitropin alpha; Follitropin
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: follitropin alfa; follicle stimulating hormone; hormones, hormone substitutes, and hormone antagonists; physiological effects of drugs; biosimilar; bioequivalence