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A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults

NCT02777554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-07-22

Study results available
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Summary

The purpose of this study is to evaluate the relative bioavailability of apremilast once-daily formulation relative to a twice daily formulation when administered as multiple doses (Part 1), and when administered as a single dose under fasting and fed conditions (Part 2). Information on safety and tolerability will also be obtained.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Apremilast IR

Apremilast immediate release tablet

DRUG

Apremilast XL

Apremilast extended release formulation tablet

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-08-17
Primary Completion
2016-11-22
Completion
2016-11-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02777554 on ClinicalTrials.gov