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Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)

NCT06595121 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-08

No results posted yet for this study

Summary

This study aims to demonstrate the bioequivalence between the formulation of Budesonide 1mg/2mL nebuliser suspension (IMP 08P1707F0) relaive to the reference product Pulmicort(r) 1.0mg/2mL suspension.

Conditions

  • Healthy

Interventions

DRUG

budesonide

Budesonide 1 mg/2mL nebuliser suspension

DRUG

budesonide

Pulmicort(r) 1 mg/2mL nebuliser suspension

OTHER

Activated Charcoal

suspension of 10g activated charcoal slurried in 70mL of water

Sponsors & Collaborators

  • Analytical Clinical Concepts (ACC GmbH)

    collaborator UNKNOWN

  • Unither Pharmaceuticals, France

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2024-09-16
Completion
2024-09-16

Countries

  • Turkey (Türkiye)

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 NCT06595121 on ClinicalTrials.gov