drugset / Trial / NCT01141270
Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application
RandomizedCrossoverOpen-label
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®).
Timeline
- Start
- 2009-01
- Primary completion
- 2009-08
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gonal-f | Protein / enzyme biologic | 225 iu | Subcutaneous |
Indications
No indication recorded.