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

NCT02800824 | Completed Phase 1

• 1 other identifier: PRG-NY-16-007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Budesonide rectal foam

EXPERIMENTAL

Drug: Budesonide

Uceris rectal foam

ACTIVE COMPARATOR

Drug: Uceris

Interventions

Budesonide DRUG

Budesonide rectal foam

Uceris DRUG

Uceris rectal foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• History or presence or of diabetes mellitus, glaucoma or cataracts, hypertension, or osteoporosis
• History of drug or alcohol addiction requiring treatment.
• History of malabsorption within the last year.
• Presence of hepatic or renal dysfunction.
• Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
• Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.

Sponsors & Collaborators

• Padagis LLC: lead

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 15, 2016
• Primary Completion: June 1, 2016
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share