Status:
COMPLETED
In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
Lead Sponsor:
Sandoz
Conditions:
Healthy Volunteers
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Healthy males and females aged 30 to 65 years
- Body mass index 18.0 to 32.0 kg/m2
Exclusion
- None
Key Trial Info
Start Date :
December 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05429775
Start Date
December 26 2018
End Date
January 29 2019
Last Update
June 23 2022
Active Locations (1)
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1
Sandoz Investigative Site
Nottingham, England, United Kingdom, NG11 6JS