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Bioequivalence Study of Budesonide From Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) Versus Uceris 9 mg Extended Release Tablets (Man. for: Salix Pharm., a Division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by License of Cosmo Tech. Ltd., Ireland, Product of France)

NCT04854538 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-22

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 Budesonide from Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) versus Uceris 9 mg Extended Release tablets (Man. for: Salix Pharm., a division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by license of Cosmo Tech. Ltd., Ireland, Product of France) in Healthy Human Volunteers Under Fasting Condition.

Conditions

  • Healthy

Interventions

DRUG

Ekmasonid

1 extended release tablet contains 9 mg Budesonide

DRUG

Uceris (first dose)

1 extended release tablet contains 9 mg Budesonide

DRUG

Uceris (second dose)

1 extended release tablet contains 9 mg Budesonide

Sponsors & Collaborators

  • Hikma Pharmaceuticals LLC

    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
2020-09-17
Primary Completion
2020-10-01
Completion
2020-12-04

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 NCT04854538 on ClinicalTrials.gov