HealthyPhase 1BUNIPILOTNCT06595121
Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)
A Phase 1 study testing budesonide and Activated Charcoal in people with Healthy, run by Unither Pharmaceuticals, France at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- budesonide and Activated Charcoal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2024to 16 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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 (...)
Who cannot join
- 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 (...)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- budesonide, Activated Charcoal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
Also called IMP 08P1707F0
Budesonide 1 mg/2mL nebuliser suspension
budesonideDrug
Pulmicort(r) 1 mg/2mL nebuliser suspension
Activated CharcoalOther
suspension of 10g activated charcoal slurried in 70mL of water
| Study group | Role | What they receive |
|---|---|---|
| IMP 08P1707F0 without charcoal | Experimental | Budesonide 1mg/2mL nebuliser suspension (08P1707F0) without charcoal Receives: Drug: budesonide |
| IMP 08P1707F0 with charcoal | Experimental | Budesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal Receives: Drug: budesonide; Other: Activated Charcoal |
| Pulmicort 1.0mg/2mL Suspension | Active comparator | Pulmicort 1.0mg/2mL Suspension (First administration) Receives: Drug: budesonide |
| Pulmicort 1.0mg/ML suspension (second administration) | Active comparator | Pulmicort 1.0mg/ML suspension (second administration) Receives: Drug: budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of budesonide for the differents arms
The maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42 and 0.50 hours
t max of budesonide for the differents arms
Measured: 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
Measured: 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
Measured: predose, 0.05, .010, 0.17 and 0.25 hours
λz of budesonide for the differents arms
λz Elimination rate constant (calculated by log linear regression of concentrations observed during the terminal phase of elimination)
Measured: 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
Incidence of treatment-related adverse events
Occurence and severity of adverse events (serious and non serious adverse events)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Aug 2024
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single dose, randomized, open-label, two-formations, three treatments, four-period, four-sequence, cross-over, at one study site.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analytical Clinical Concepts (ACC GmbH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595121
- Sponsor's protocol ID
- UP-CLI-2022-001
- Acronym
- BUNIPILOT
- Status last verified
- Oct 2024
- First submitted
- 6 Sep 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06595121
- Acronym / sponsor ID
- BUNIPILOT / UP-CLI-2022-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
- Collaborators
- Analytical Clinical Concepts (ACC GmbH)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single dose, randomized, open-label, two-formations, three treatments, four-period, four-sequence, cross-over, at one study site.
| Arm | Type | Receives |
|---|---|---|
| IMP 08P1707F0 without charcoal | Experimental | Drug: budesonideBudesonide 1mg/2mL nebuliser suspension (08P1707F0) without charcoal |
| IMP 08P1707F0 with charcoal | Experimental | Drug: budesonide, Other: Activated CharcoalBudesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal |
| Pulmicort 1.0mg/2mL Suspension | Active comparator | Drug: budesonidePulmicort 1.0mg/2mL Suspension (First administration) |
| Pulmicort 1.0mg/ML suspension (second administration) | Active comparator | Drug: budesonidePulmicort 1.0mg/ML suspension (second administration) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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 (...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonideAlso: IMP 08P1707F0Budesonide 1 mg/2mL nebuliser suspension | Drug | IMP 08P1707F0 with charcoal, IMP 08P1707F0 without charcoal |
| budesonidePulmicort(r) 1 mg/2mL nebuliser suspension | Drug | Pulmicort 1.0mg/2mL Suspension, Pulmicort 1.0mg/ML suspension (second administration) |
| Activated Charcoalsuspension of 10g activated charcoal slurried in 70mL of water | Other | IMP 08P1707F0 with charcoal |
Primary outcome
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
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
8 secondary outcomes
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
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
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
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
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
AUC O-15 min of budesonide for the differents arms
Time frame: predose, 0.05, .010, 0.17 and 0.25 hours
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
Incidence of treatment-related adverse events
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing budesonide and Activated Charcoal in people with Healthy, run by Unither Pharmaceuticals, France at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.