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

NCT01141270 | Completed Phase 1

• 1 other identifier: FIN1001
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Keywords

recombinant human follicle stimulating hormone; pharmacokinetics; bioequivalence

Outcome Measures

Primary Outcomes (1)

• Area under the serum concentration curve (AUC) of FSH

  0 -192h after FSH injection

Study Arms (2)

AFOLIA

EXPERIMENTAL

225 IU sc

Drug: AFOLIA

Gonal-f

ACTIVE COMPARATOR

225 IU sc

Drug: Gonal-f

Interventions

AFOLIA DRUG

single sc injection, 225 IU

AFOLIA

Gonal-f DRUG

single sc injection, 225IU

Gonal-f

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polymun Scientific GmbH: lead

MeSH Terms

Interventions

follitropin alfa

Study Officials

• Michael Wolzt, aoUniv.Prof.

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: January 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: July 1, 2010
• Last Updated: August 4, 2010

Record last verified: 2010-08