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Cortiment® MMX Pharmacokinetic Study

NCT04080713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-10-21

No results posted yet for this study

Summary

Budesonide is a well-known and well-characterised locally acting glucocorticosteroid with comparable efficacy to that of conventional glucocorticosteroids, but with fewer systemic side effects due to its low bioavailability following oral administration.

There are no benefits for subjects participating in this pharmacokinetic (PK) profile and safety study. This is an open-label study to investigate the PK profile and safety of single oral dose of budesonide prolonged release tablets (9 mg, Cortiment® MMX \[multi-matrix system\]) in healthy subjects in Indian population.

Two study visits are planned: One out-patient visit (screening) and one residential session consisting of three consecutive nights (admission to the clinical investigation unit at least 12 hours before dosing and discharge approximately 60 hours after dosing). End-of-study assessments will be performed before discharge from the clinical investigation unit in the single dosing period. Subjects should be in the fasted state for at least 10 hours pre-dose.

Number of subjects planned in total in the study are 24 men and women, with a minimum requirement of 7 women. The safety assessments comprise of adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory variables. Adverse events will be collected throughout the study.

Conditions

  • Healthy

Interventions

DRUG

Budesonide

Budesonide 9 mg prolonged release tablet

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2019-09-25
Completion
2019-09-25

Countries

  • India

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 NCT04080713 on ClinicalTrials.gov