NCT02671058

Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories

Randomized, Open Label, Crossover Study Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Administered as a Suppository With the Sephure® Rectal Suppository Applicator Compared With Cortenema in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cristcot LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Screening evaluations will occur from Day 28 to Day 2 and subjects will be confined to the clinical research unit (CRU) from Day 1 to Day 2 for each treatment period. The treatment periods will be separated by at least a 7 day washout period. Subjects meeting the study enrollment criteria will be randomly assigned to 1 of 2 sequences (AB or BA) on Day 1 of Treatment Period 1 and will receive either the reference product (A) or the treatment product (B) once during the study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cortenema	Hydrocortisone Administered as a Liquid Enema
DRUG	Hydrocortisone Acetate	Hydrocortisone Acetate Administered as a Suppository with the Sephure® Rectal Suppository Applicator

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-05-24
• Completion: 2016-05-24
• First posted: 2016-02-02
• Last updated: 2017-07-28