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

NCT05429775 | Completed Phase 1

• 1 other identifier: SAN-0385/1828-BUD-3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Number of adverse events

  throughout the study, approximately 13 weeks

Study Arms (4)

Budesonide: Formulation 1

EXPERIMENTAL

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

Drug: Budesonide

Budesonide: Formulation 2

EXPERIMENTAL

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

Drug: Budesonide

Budesonide: Formulation 3

EXPERIMENTAL

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

Drug: Budesonide

Budesonide: Formulation 4

EXPERIMENTAL

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

Drug: Budesonide

Interventions

Budesonide DRUG

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

Budesonide: Formulation 1; Budesonide: Formulation 2; Budesonide: Formulation 3; Budesonide: Formulation 4

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Sandoz Investigative Site

Nottingham, England, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sandoz

  Sandoz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 23, 2022
• Study Start: December 26, 2018
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

GB (1)