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

Sponsor

Padagis LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02800824

Collaborator

(none)

Arms

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Budesonide Drug: Uceris	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Actual Primary Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Budesonide rectal foam	Drug: Budesonide
Active Comparator: Uceris rectal foam	Drug: Uceris

Arm

Intervention/Treatment

Experimental: Budesonide rectal foam

Drug: Budesonide

Active Comparator: Uceris rectal foam

Drug: Uceris

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Padagis LLC

ClinicalTrials.gov Identifier:

NCT02800824

Other Study ID Numbers:

PRG-NY-16-007

First Posted:

Jun 15, 2016

Last Update Posted:

Jan 13, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Budesonide

Study Results

No Results Posted as of Jan 13, 2022