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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

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Actual Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

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



Primary Outcome Measures :
  1. Maximum observed plasma drug concentration (Cmax) [ Time Frame: 24 hours ]
  2. AUC from time 0 extrapolated to infinity (AUC0-∞) [ Time Frame: 24 hours ]
  3. AUC from time 0 to 24 hours (AUC0-24) [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT02800824    
Other Study ID Numbers: PRG-NY-16-007
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists