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Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules

NCT02841150 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-03-29

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

IMBRUVICA (Treatment A)

IMBRUVICA (reference treatment), 4\*140 milligram (mg), capsules.

DRUG

Ibrutinib (Treatment B)

Ibrutinib (test treatment), 1\*560 mg, tablet.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-08-31
Completion
2016-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02841150 on ClinicalTrials.gov