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Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02800824
Enrollment
Unknown
Registered
2016-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To evaluate the bioequivalence between the Test Product Budesonide rectal aerosol foam and Reference Product Uceris® rectal aerosol foam after a single-dose in healthy subjects

Interventions

DRUGBudesonide
DRUGUceris

Sponsors

Padagis LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Healthy, non-smoking, male and female subjects, 18 years of age or over. 2. No clinically significant findings in vital signs measurements or 12-lead electrocardiogram (ECG) or abnormal laboratory values. 3. Have no significant diseases. 4. Willing to use an acceptable, effective method of contraception. 5. Informed on the nature of the study and have agreed to and are able to read, review and sign all consent documents. 6. Have no clinically significant findings from a physical examination.

Exclusion criteria

1. Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results 2. Known history or presence of hypersensitivity or idiosyncratic reaction to budesonide, any other components of the drug products, or any other drug substances with similar activity or sodium phosphate 3. History or presence or of diabetes mellitus, glaucoma or cataracts, hypertension, or osteoporosis 4. History of drug or alcohol addiction requiring treatment. 5. History of malabsorption within the last year. 6. Presence of hepatic or renal dysfunction. 7. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. 8. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.

Design outcomes

Primary

MeasureTime frame
Maximum observed plasma drug concentration (Cmax)24 hours
AUC from time 0 extrapolated to infinity (AUC0-∞)24 hours
AUC from time 0 to 24 hours (AUC0-24)24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026