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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01141270

Enrollment

Registered

2010-06-10

Start date

2009-01-31

Completion date

2010-07-31

Last updated

2010-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

recombinant human follicle stimulating hormone, pharmacokinetics, bioequivalence

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®).

Interventions

DRUGAFOLIA

single sc injection, 225 IU

DRUGGonal-f

single sc injection, 225IU

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026