Healthy Volunteers
Conditions
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.
Interventions
DRUGBudesonide
single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Sponsors
Sandoz
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time at which 50% radiolabel administered has arrived in the oesophagus from the mouth (T50%) (min) | During procedure | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. |
| Total oesophageal transit time | 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) | 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 | 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) | 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) | During procedure | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | throughout the study, approximately 13 weeks | Number of adverse events will be provided to get additional information on the safety and tolerability of budesonide suspension formulations after oral administration. |
Countries
United Kingdom
Outcome results
None listed