drugset / Trial / NCT07312643
Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule
RandomizedCrossoverOpen-labelOther
Summary
This single-center Phase 1 study in healthy male and female subjects of 18 to 55 years (inclusive) will follow an open-label, randomized, single-dose, crossover design with 2 intervention periods. The purpose of this study is to assess and compare the pharmacokinetic characteristics and the safety of single doses of pasireotide when administered subcutaneously by reusable ServoPen with cartridge or by syringe drawn from an ampule in healthy subjects.
Timeline
- Start
- 2025-12-01
- Primary completion
- 2026-02-03
- Completion
- 2026-02-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pasireotide | Other / unclassified | 50 ug | Subcutaneous |
| Comparator | Pasireotide | Other / unclassified | 200 ug | Subcutaneous |
Indications
No indication recorded.