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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: budesonide; Other: Activated Charcoal

• Registration Number: NCT06595121
• Lead Sponsor: Unither Pharmaceuticals, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-13
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-10
• Primary Completion: 2024-09-16
• Study Completion: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy, Caucasian, male and female (16 male, 8 female) subjects 18 - 55 years of age
• Body mass index within the range of ≥ 18.5 and ≤ 30.0 kg/m2
• Female subjects of childbearing potential1) agree to undergo pregnancy tests and to use at least an acceptable effective birth control method during the study and until 90 days after study end
• Negative Covid-19 test result
• Findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
• Findings within the range of clinical acceptability in physical examination (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
• Laboratory values within the normal range (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
• Normal Electrocardiograms (ECG) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study
• Normal vital signs (normal blood pressure and heart rate measured under stabilised conditions at screening visit after at least 5 minutes of rest in sitting position: systolic blood pressure 100 - 140 mmHg, diastolic blood pressure 60 - 90 mmHg and heart rate 50 - 100 beats per minute; normal body temperature (Forehead, 35.5 °C - 37.0 °C)) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study (...)

Exclusion Criteria

• History of hypersensitivity to the study drug or any related drugs or to any of the excipients
• History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, malignant disease or eye disorders as glaucoma or a family history of glaucoma
• Clinically significant abnormal laboratory values
• Clinically significant ECG findings
• Clinically significant vital signs (...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IMP 08P1707F0 without charcoal	budesonide	Budesonide 1mg/2mL nebuliser suspension (08P1707F0) without charcoal
IMP 08P1707F0 with charcoal	budesonide	Budesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal
IMP 08P1707F0 with charcoal	Activated Charcoal	Budesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal
Pulmicort 1.0mg/2mL Suspension	budesonide	Pulmicort 1.0mg/2mL Suspension (First administration)
Pulmicort 1.0mg/ML suspension (second administration)	budesonide	Pulmicort 1.0mg/ML suspension (second administration)

Primary Outcome Measures

Name	Time	Method
Cmax of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours	The maximum concentration in plasma among observed concentrations at pre-specified time points
AUC 0-t of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours	The area under the curve of plasma concentration versus time curve from time O to the last measured concentration

Secondary Outcome Measures

Name	Time	Method
AUC 0-∞ of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours
AUC t-∞ of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours
AUC O-30 min of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42 and 0.50 hours
t max of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours
t 1/2 of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours
AUC O-15 min of budesonide for the differents arms	predose, 0.05, .010, 0.17 and 0.25 hours
λz of budesonide for the differents arms	predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours	λz Elimination rate constant (calculated by log linear regression of concentrations observed during the terminal phase of elimination)
Incidence of treatment-related adverse events	up to 24 hours	Occurence and severity of adverse events (serious and non serious adverse events)

Trial Locations

Locations (1)

Farmagen IKU Merkezi; 🇹🇷 Gaziantep, Turkey