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

NCT06595121 | Completed Phase 1

• 1 other identifier: UP-CLI-2022-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax of budesonide for the differents arms

  The maximum concentration in plasma among observed concentrations at pre-specified time points

  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 0-t of budesonide for the differents arms

  The area under the curve of plasma concentration versus time curve from time O to the last measured concentration

  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

Secondary Outcomes (8)

• 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

Study Arms (4)

IMP 08P1707F0 without charcoal

EXPERIMENTAL

Budesonide 1mg/2mL nebuliser suspension (08P1707F0) without charcoal

Drug: budesonide

IMP 08P1707F0 with charcoal

EXPERIMENTAL

Budesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal

Drug: budesonide; Other: Activated Charcoal

Pulmicort 1.0mg/2mL Suspension

ACTIVE COMPARATOR

Pulmicort 1.0mg/2mL Suspension (First administration)

Drug: budesonide

Pulmicort 1.0mg/ML suspension (second administration)

ACTIVE COMPARATOR

Pulmicort 1.0mg/ML suspension (second administration)

Drug: budesonide

Interventions

budesonide DRUG

Budesonide 1 mg/2mL nebuliser suspension

Also known as: IMP 08P1707F0

IMP 08P1707F0 with charcoal; IMP 08P1707F0 without charcoal

Activated Charcoal OTHER

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

IMP 08P1707F0 with charcoal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 (...)

You may not qualify if:

• 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 (...)

Sponsors & Collaborators

• Unither Pharmaceuticals, France: lead
• Analytical Clinical Concepts (ACC GmbH): collaborator

Study Sites (1)

Farmagen IKU Merkezi

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Budesonide; Charcoal

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Carbon; Elements; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose, randomized, open-label, two-formations, three treatments, four-period, four-sequence, cross-over, at one study site.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 13, 2024
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study

Locations

TU (1)