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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Budesonide; Drug: Uceris

• Registration Number: NCT02800824
• Lead Sponsor: Padagis LLC

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

Detailed Description

Not available

Study Timeline

• Primary Completion: 2016-06
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Budesonide rectal foam	Budesonide	-
Uceris rectal foam	Uceris	-

Primary Outcome Measures

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