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

December 23, 2021 updated by: Padagis LLC
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma drug concentration (Cmax)
Time Frame: 24 hours
24 hours
AUC from time 0 extrapolated to infinity (AUC0-∞)
Time Frame: 24 hours
24 hours
AUC from time 0 to 24 hours (AUC0-24)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Padagis LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRG-NY-16-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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