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

Padagis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Uceris; Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02800824

PRG-NY-16-007

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Budesonide rectal foam

Experimental group

Treatment:

Drug: Budesonide

Uceris rectal foam

Active Comparator group

Treatment:

Drug: Uceris