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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Budesonide

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Nottingham, England, United Kingdom, NG11 6JS
      • Sandoz Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Budesonide: Formulation 1; single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions	Drug: Budesonide; single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Experimental: Budesonide: Formulation 2; single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions	Drug: Budesonide; single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Experimental: Budesonide: Formulation 3; single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions	Drug: Budesonide; single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Experimental: Budesonide: Formulation 4; single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions	Drug: Budesonide; single dose of 2 mg oral suspension formulation administered orally under fasting conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total oesophageal transit time	A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.	During procedure
Time at which 10% radiolabel administered has arrived in the oesophagus from the mouth (T10%) (min)	A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.	During procedure
Time at which 50% radiolabel administered has arrived in the oesophagus from the mouth (T50%) (min)	A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.	During procedure
Time at which the amount of radiolabel present in the oesophagus peaks (Tmax) (min)	A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.	During procedure
Time at which 90% of the radiolabel present at Tmax has left the oesophagus (T90%) (min)	A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.	During procedure
Total amount of radiolabel present in the oesophagus and the three regions over time	A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Number of adverse events will be provided to get additional information on the safety and tolerability of budesonide suspension formulations after oral administration.	throughout the study, approximately 13 weeks

Collaborators and Investigators

• Sponsor: Sandoz

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2018
• Primary Completion (Actual): January 29, 2019
• Study Completion (Actual): January 29, 2019

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: SAN-0385/1828-BUD-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No