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

NCT07312643

Phase 1 Completed 40 enrolled RECORDATI GROUP Nuvisan · collab
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

EvaluationDrugModalityDoseRoute
Comparator Pasireotide Other / unclassified 50 ug Subcutaneous
Comparator Pasireotide Other / unclassified 200 ug Subcutaneous

Indications

No indication recorded.