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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sandoz
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Total oesophageal transit time
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy males and females aged 30 to 65 years
- •Body mass index 18.0 to 32.0 kg/m2
Exclusion Criteria
- Not provided
Arms & Interventions
Budesonide: Formulation 1
single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions
Intervention: Budesonide (Drug)
Budesonide: Formulation 2
single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions
Intervention: Budesonide (Drug)
Budesonide: Formulation 3
single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions
Intervention: Budesonide (Drug)
Budesonide: Formulation 4
single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions
Intervention: Budesonide (Drug)
Outcomes
Primary Outcomes
Total oesophageal transit time
Time Frame: During procedure
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
Time at which 10% radiolabel administered has arrived in the oesophagus from the mouth (T10%) (min)
Time Frame: During procedure
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
Time at which the amount of radiolabel present in the oesophagus peaks (Tmax) (min)
Time Frame: During procedure
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
Time at which 90% of the radiolabel present at Tmax has left the oesophagus (T90%) (min)
Time Frame: During procedure
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
Time at which 50% radiolabel administered has arrived in the oesophagus from the mouth (T50%) (min)
Time Frame: During procedure
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
Total amount of radiolabel present in the oesophagus and the three regions over time
Time Frame: During procedure
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
Secondary Outcomes
- Number of adverse events(throughout the study, approximately 13 weeks)