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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide: Formulation 1 | Experimental | single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions |
|
| Budesonide: Formulation 2 | Experimental | single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions |
|
| Budesonide: Formulation 3 | Experimental | single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions |
|
| Budesonide: Formulation 4 | Experimental | single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | single dose of 2 mg oral suspension formulation administered orally under fasting conditions |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandoz | Sandoz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigative Site | Nottingham | England | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| During procedure |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |