Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application

Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application. A Randomised, Open Label, Cross Over Study

Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the reference product (Gonal-f®).

Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AFOLIA; Drug: Gonal-f

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy female volunteers
• Age between 18-38 years
• Body mass index 17-29 kg/m2
• Woman of child bearing potential must agree to practice effective barrier methods for birth control
• Use of oral contraceptives for at least 3 months before study entry
• Regular menstruation cycle (25-34 days) before initiation of oral contraception
• Presence of both ovaries
• Normal findings in medical history and physical and gynaecological examination unless the investigator considers an abnormality to be clinically irrelevant for this study
• Signed informed consent

Exclusion Criteria:

• Polycystic ovary syndrome (PCOS)
• History of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome, OHSS)
• Impaired thyroid function (treated or untreated)
• History of malignant disease
• AST and/or ALAT > 2 x ULN
• Other clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
• Smoking habits of more than 5 cigarettes per day
• Abuse of alcoholic beverages and drugs
• Participation in a clinical trial within 3 weeks prior to the study
• Foreseen inability to attend to scheduled study visits
• Symptoms of a clinically relevant illness during 3 weeks prior the first study day
• Pregnancy or lactation period
• Any medical condition that, in the opinion of the investigator, would interfere with safety of the subject or interference of the objectives of the study

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AFOLIA; 225 IU sc	Drug: AFOLIA; single sc injection, 225 IU
Active Comparator: Gonal-f; 225 IU sc	Drug: Gonal-f; single sc injection, 225IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the serum concentration curve (AUC) of FSH	0 -192h after FSH injection

Collaborators and Investigators

• Sponsor: Polymun Scientific GmbH
• Investigators: Principal Investigator: Michael Wolzt, aoUniv.Prof., Medical University Vienna

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Estimate): August 4, 2010
• Last Update Submitted That Met QC Criteria: August 3, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: pharmacokinetics; bioequivalence; recombinant human follicle stimulating hormone
• Other Study ID Numbers: FIN1001