drugset / Trial / NCT02459418
Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application
RandomizedCrossoverOpen-labelOther
Summary
Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of Afolia.
Timeline
- Start
- 2015-05-07
- Primary completion
- 2016-05-19
- Completion
- 2016-05-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonal-f | Protein / enzyme biologic | 225 iu | Subcutaneous |
Indications
No indication recorded.