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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05429775

SAN-0385/1828-BUD-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females aged 30 to 65 years
• Body mass index 18.0 to 32.0 kg/m2

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Budesonide: Formulation 1

Experimental group

Description:

single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions

Treatment:

Drug: Budesonide

Budesonide: Formulation 2

Experimental group

Description:

single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions

Treatment:

Drug: Budesonide

Budesonide: Formulation 3

Experimental group

Description:

single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions

Treatment:

Drug: Budesonide

Budesonide: Formulation 4

Experimental group

Description:

single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions

Treatment:

Drug: Budesonide