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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800824
• Other study ID #: PRG-NY-16-007
• Status: Completed
• Phase: Phase 1

Study information

• Verified date: December 2021
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Budesonide

• Uceris

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma drug concentration (Cmax)		24 hours
Primary	AUC from time 0 extrapolated to infinity (AUC0-8)		24 hours
Primary	AUC from time 0 to 24 hours (AUC0-24)		24 hours