drugset / Trial / NCT04899193
Pergoveris FD and Liquid China BE Study
Phase 1
Completed
72 enrolled
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
RandomizedCrossoverOpen-labelOther
Summary
The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in Pergoveris Liquid (Test 2) versus the co-administration of Gonal-f and Luveris (Reference), administered subcutaneously (SC) in pituitary suppressed, healthy premenopausal Chinese female participants, at the doses of 900 international unit (IU) of follitropin alfa and 450 IU lutropin alfa.
Timeline
- Start
- 2021-05-08
- Primary completion
- 2022-05-28
- Completion
- 2022-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luveris | Protein / enzyme biologic | 450 iu | Subcutaneous |
| Subject | Pergoveris | Protein / enzyme biologic | 450 iu | Subcutaneous |
| Subject | Pergoveris | Protein / enzyme biologic | 900 iu | Subcutaneous |
| Subject | folitropin alfa | Protein / enzyme biologic | 900 iu | Subcutaneous |
Indications
No indication recorded.