Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800824
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date June 15, 2016
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June¬†9,¬†2016)
  • Maximum observed plasma drug concentration (Cmax) [ Time Frame: 24 hours ]
  • AUC from time 0 extrapolated to infinity (AUC0-∞) [ Time Frame: 24 hours ]
  • AUC from time 0 to 24 hours (AUC0-24) [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Budesonide
  • Drug: Uceris
Study Arms  ICMJE
  • Experimental: Budesonide rectal foam
    Intervention: Drug: Budesonide
  • Active Comparator: Uceris rectal foam
    Intervention: Drug: Uceris
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800824
Other Study ID Numbers  ICMJE PRG-NY-16-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Perrigo Company
Study Sponsor  ICMJE Perrigo Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Perrigo Company
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP