Pharmacokinetics Clinical Trial
Official title:
Study of Safety, Tolerance and Pharmacokinetics of Primapur and Gonal-f Upon Single-dose Subcutaneous Administration in Healthy Volunteers
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.
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.
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