NCT05429775

In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

A Single Part, Four Period Sequential, Open Label Study Designed to Evaluate the In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single centre, open-label, sequential, single dose 4-period crossover, scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.

Detailed description

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. For each treatment period, subjects will be admitted to the clinical unit on the evening prior to IMP administration (Day -1) and will fast overnight for a minimum of 8 h. On the morning of Day 1, subjects will receive IMP in the fasted state and will remain on site until 24 h post-dose. Following Period 2, there will be an interim analysis and review of safety and scintigraphy data from dosed regimens in order to determine which formulations will be used in subsequent periods. A follow-up phone call will take place 3 to 5 days post-final dose to ensure the ongoing wellbeing of the subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Budesonide	single dose of 2 mg oral suspension formulation administered orally under fasting conditions

Timeline

• Start date: 2018-12-26
• Primary completion: 2019-01-29
• Completion: 2019-01-29
• First posted: 2022-06-23
• Last updated: 2022-06-23

Locations

1 site across 1 country: United Kingdom