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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429775
• Other study ID #: SAN-0385/1828-BUD-3
• Status: Completed
• Phase: Phase 1
• Start date: December 26, 2018
• Est. completion date: January 29, 2019

Study information

• Verified date: June 2022
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males and females aged 30 to 65 years

• Body mass index 18.0 to 32.0 kg/m2

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Budesonide
single dose of 2 mg oral suspension formulation administered orally under fasting conditions

Locations

Country	Name	City	State
United Kingdom	Sandoz Investigative Site	Nottingham	England

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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