Clinical Trial

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

Study acronym: PASIPHY_PEN
Completed Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-16.
Status change: Recruiting → Completed 2026-02-03
Trial Details
NCT Number NCT07312643
Lead Sponsor RECORDATI GROUP
Collaborators: Nuvisan
Conditions Pharmacokinetics, Safety
Enrollment 40 participants
Start Date 2025-12-01
Primary Completion 2026-02-03 (estimated)
Study Completion 2026-02-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-04