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

NCT ID: NCT01141270

Last Updated: 2010-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-07-31

Brief Summary

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®).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

AFOLIA

225 IU sc

Group Type: EXPERIMENTAL

AFOLIA

Intervention Type: DRUG

single sc injection, 225 IU

Gonal-f

225 IU sc

Group Type: ACTIVE_COMPARATOR

Gonal-f

Intervention Type: DRUG

single sc injection, 225IU

Interventions

AFOLIA

single sc injection, 225 IU

Intervention Type: DRUG

Gonal-f

single sc injection, 225IU

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Polymun Scientific GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Polymun Scientific GmbH

Principal Investigators

Michael Wolzt, aoUniv.Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Other Identifiers

FIN1001

Identifier Type: -

Identifier Source: org_study_id