Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application
- Registration Number
- NCT01141270
- Lead Sponsor
- Polymun Scientific GmbH
- 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®).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AFOLIA AFOLIA 225 IU sc Gonal-f Gonal-f 225 IU sc
- Primary Outcome Measures
Name Time Method Area under the serum concentration curve (AUC) of FSH 0 -192h after FSH injection
- Secondary Outcome Measures
Name Time Method