FIN1002 PK of AFOLIA and US Gonal-f® RFF Redi-ject SC
Research type
Research Study
Full title
Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject after single subcutaneous application. A randomised, open label, 2-way cross-over study
IRAS ID
168570
Contact name
Ronnie Beboso
Contact email
Sponsor organisation
FINOX AG
Eudract number
2014-004763-20
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
The purpose of this study is to evaluate how AFOLIA and US Gonal-f® RFF Redi-ject are absorbed and removed from the bloodstream after single doses given by injection under the skin and to establish that the two products are the same.
AFOLIA and US Gonal-f® RFF Redi-ject are recombinant human follicle-stimulating hormone (r-hFSH). They are similar to natural Follicle-stimulating hormone (FSH) but made in the laboratory. FSH is a hormone (protein) that plays a role in regulating reproductive function in males and females.
AFOLIA is approved in Europe and is marketed under the trade name BEMFOLA. US Gonal-f® RFF Redi-ject is also an approved and marketed drug. Both drugs are used to help induce ovulation (egg production) and pregnancy in women having difficulty ovulating and also to help develop multiple follicles (eggs) in women who can ovulate naturally participating in an Assisted Reproductive Technology program.
During this study, volunteers will also receive LupronDepot® (an approved and marketed hormonal medication), given intra-muscularly in order to suppress the natural production of FSH in the body.
At least 44 healthy female volunteers will be dosed with LupronDepot®. Up to 30 healthy female volunteers will be dosed with FSH (AFOLIA and US Gonal-f® RFF Redi-ject).
Each volunteer will receive one of the study medications at least 10 days after first administration of LupronDepot®. They will be admitted for 3 days and 2 nights if they fulfil all the required criteria for dosing with the study drug. They will receive a second LupronDepot® injection on day 16 and re-admitted to the clinic on day 26 for 3 days and 2 nights for administration of the second study medication.
Blood samples for determination of the level of the study drug in the blood will be collected in each subject at various time-points pre-dose and post-dose.REC name
HSC REC A
REC reference
15/NI/0018
Date of REC Opinion
31 Mar 2015
REC opinion
Further Information Favourable Opinion