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Bioequivalence Study of Baricitinib From Barcimiant 4 mg Film Coated Tablets (Horus Pharma, Egypt) and Olumiant 4 mg Film Coated Tablets (Eli Lilly Nederland B.V., The Netherlands)

NCT05006768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-16

No results posted yet for this study

Summary

Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Baricitinib from Barcimiant 4 mg Film Coated Tablets (Horus Pharma, Egypt) and Olumiant 4 mg Film Coated Tablets (Eli Lilly Nederland B.V., The Netherlands)

Conditions

  • Healthy

Interventions

DRUG

Barcimiant

1 tablet contains 4 mg Barcitinib

DRUG

Olumiant (first dose)

1 tablet contains 4 mg Barcitinib

DRUG

Olumiant (second dose)

1 tablet contains 4 mg Barcitinib

Sponsors & Collaborators

  • Horus Pharma

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

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
2021-05-05
Primary Completion
2021-06-03
Completion
2021-06-24

Countries

  • Egypt

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 NCT05006768 on ClinicalTrials.gov