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

Polymun Scientific

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Gonal-f

Drug: AFOLIA

Study type

Interventional

Funder types

Industry

Identifiers

NCT01141270

FIN1001

Details and patient eligibility

About

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®).

Enrollment

32 patients

Sex

Female

Ages

18 to 38 years old

Volunteers

Accepts Healthy Volunteers

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