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Completed

NCT Number: NCT06595121

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Farmagen IKU Merkezi

Gaziantep, 27000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (...)

Treatment and study plan

Budesonide

Drug

Budesonide 1 mg/2mL nebuliser suspension

Other names: IMP 08P1707F0

Activated Charcoal

Other

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

Primary outcomes

  1. Cmax of budesonide for the differents arms

    Time frame: 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

  2. AUC 0-t of budesonide for the differents arms

    Time frame: 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 outcomes

  1. AUC 0-∞ of budesonide for the differents arms

    Time frame: 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

  2. AUC t-∞ of budesonide for the differents arms

    Time frame: 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

  3. AUC O-30 min of budesonide for the differents arms

    Time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42 and 0.50 hours

  4. t max of budesonide for the differents arms

    Time frame: 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

  5. t 1/2 of budesonide for the differents arms

    Time frame: 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

  6. AUC O-15 min of budesonide for the differents arms

    Time frame: predose, 0.05, .010, 0.17 and 0.25 hours

  7. λz of budesonide for the differents arms

    Time frame: 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)

  8. Incidence of treatment-related adverse events

    Time frame: up to 24 hours

    Occurence and severity of adverse events (serious and non serious adverse events)

Sponsors and collaborators

Lead sponsor

Unither Pharmaceuticals, France

Industry

Collaborators

  • Analytical Clinical Concepts (ACC GmbH)

Registry information

Official study title

Comparative Bioavailability Study of Budesonide After Inhalation of Budesonide 1 Mg / 2 Ml Nebuliser Suspension (Test Product 08P1707F0): Administration Without and with Activated Charcoal and Inhalation of Pulmicort® 1.0 Mg / 2 Ml Suspension (Reference Product) in Healthy Subjects

Acronym: BUNIPILOT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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