drugset / Trial / NCT03810664
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
RandomizedCrossoverOpen-labelOther
Summary
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Timeline
- Start
- 2019-01-18
- Primary completion
- 2019-04-19
- Completion
- 2019-04-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatrogon | Protein / enzyme biologic | 12 mg | Subcutaneous |
Indications
No indication recorded.