CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
Baricitinib suspension +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03212638
NCT03212638Phase 1Completed

A Bioequivalence and Food Effect Study in Healthy Subjects Comparing Baricitinib Suspension and Commercial Tablet Formulations

Eli Lilly and Company·interventional·Posted Jul 11, 2017·Updated Mar 26, 2019

In Brief

A Phase 1 clinical trial evaluating Baricitinib suspension and Baricitinib tablet for Healthy. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purposes of this study are to determine: * If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms. * How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body. * The safety and tolerability of baricitinib. The study has two parts. Individuals will participate in only one part. Participants will be admitted to the clinical research unit (CRU) and will be discharged from the CRU following the completion of 3 overnight stays. Each part of this study will last from 8-10 days, not including screening. Follow-up will occur 7 to 14 days after the last dose of baricitinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSingapore
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 11, 2017
Enrollment StartJun 27, 2017
Primary CompletionJul 31, 2017
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.0 years ago

Interventions

Baricitinib suspensiondrug

Administered orally

Baricitinib tabletdrug

Administered orally