Overview

The Safety and Pharmacokinetics of Primapur and Gonal-f

Status:
Completed
Trial end date:
2016-05-10
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
IVFarma LLC
Collaborator:
NADIM LLC
Treatments:
Ethinyl Estradiol
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists