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Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories

NCT02671058 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-07-28

No results posted yet for this study

Summary

This study will be an open label, single dose, randomized, 2 way (2 period) crossover study in healthy adult subjects at a single study center.

Conditions

  • Healthy

Interventions

DRUG

Cortenema

Hydrocortisone Administered as a Liquid Enema

DRUG

Hydrocortisone Acetate

Hydrocortisone Acetate Administered as a Suppository with the Sephure® Rectal Suppository Applicator

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Cristcot LLC

    lead INDUSTRY

Principal Investigators

  • Marck C Ensign · Executive VP Product Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-24
Completion
2016-05-24

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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 NCT02671058 on ClinicalTrials.gov