NCT03857230

The Safety and Pharmacokinetics of Primapur and Gonal-f

Study of Safety, Tolerance and Pharmacokinetics of Primapur and Gonal-f Upon Single-dose Subcutaneous Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: IVFarma LLC · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Area Under Curve
• Pharmacokinetics
• Absorption

Interventions

Type	Name	Description
DRUG	Follitropin alfa (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.
DRUG	Follitropin alfa (Gonal-F)	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.

Timeline

• Start date: 2015-10-29
• Primary completion: 2016-05-10
• Completion: 2016-05-10
• First posted: 2019-02-27
• Last updated: 2019-08-13
• Results posted: 2019-08-05

Locations

1 site across 1 country: Russia