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

NCT02800824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-01-13

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

Budesonide

DRUG

Uceris

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Primary Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02800824 on ClinicalTrials.gov