HealthyPhase 1NCT01141270
Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application
A Phase 1 study testing AFOLIA and Gonal-f in people with Healthy, run by Polymun Scientific GmbH.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AFOLIA and Gonal-f
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
About this study
Official title: Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application. A Randomised, Open Label, Cross Over Study
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
- Being tested
- AFOLIA, Gonal-f
- Keywords
- recombinant human follicle stimulating hormone, pharmacokinetics, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFOLIADrug
single sc injection, 225 IU
Gonal-fDrug
single sc injection, 225IU
| Study group | Role | What they receive |
|---|---|---|
| AFOLIA | Experimental | 225 IU sc Receives: Drug: AFOLIA |
| Gonal-f | Active comparator | 225 IU sc Receives: Drug: Gonal-f |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration curve (AUC) of FSH
Measured: 0 -192h after FSH injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polymun Scientific GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Wolzt, aoUniv.Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141270
- Sponsor's protocol ID
- FIN1001
- Status last verified
- Aug 2010
- First submitted
- 9 Jun 2010
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application. A Randomised, Open Label, Cross Over Study
- ClinicalTrials.gov ID
- NCT01141270
- Acronym / sponsor ID
- FIN1001
- Conditions
- Healthy
- Keywords
- recombinant human follicle stimulating hormone, pharmacokinetics, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Polymun Scientific GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFOLIA | Experimental | Drug: AFOLIA225 IU sc |
| Gonal-f | Active comparator | Drug: Gonal-f225 IU sc |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFOLIAsingle sc injection, 225 IU | Drug | AFOLIA |
| Gonal-fsingle sc injection, 225IU | Drug | Gonal-f |
Primary outcome
Area under the serum concentration curve (AUC) of FSH
Time frame: 0 -192h after FSH injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolzt, aoUniv.Prof. principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFOLIA and Gonal-f in people with Healthy, run by Polymun Scientific GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the serum concentration curve (AUC) of FSH (time frame: 0 -192h after FSH injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2010; AzTrials last refreshed its copy on 8 Nov 2026.