Cystic FibrosisPhase 1NCT01953367
Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects
A Phase 1 study testing Vantobra (tobramycin) and TOBI (tobramycin) in people with Cystic Fibrosis, run by Pari Pharma GmbH at 1 site in Germany.
Trial summary
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects. Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Vantobra (tobramycin) and TOBI (tobramycin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Nov 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female healthy subjects of any ethnic origin
- Aged between 18 and 50 years of age
- Body weight of ≥50 kg and body mass index (BMI) between 18.5 and 29 kg/m2
- FEV1 > 90% of predicted
- Able to demonstrate correct inhaler use
- Written informed consent
Who cannot join
- History of clinically relevant allergies or idiosyncrasies to tobramycin or any other inactive ingredient(s) of the IMP
- Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis.
- Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric or other diseases at screening
- Surgery of the gastrointestinal or respiratory tract which might interfere with drug absorption
- History of malignancy within the past 5 years
- History of orthostatic hypotension, faintings or blackouts
Show all 9Show fewer
- Acute or chronic viral, bacterial or fungal airway infections, including laryngeal infections, mouth and throat infections, and hoarseness;
- Other clinically relevant chronic or acute infectious illnesses
- Clinical chemical, hematological or any other laboratory parameters clinically relevant outside the normal range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.
Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.
- Conditions
- Cystic Fibrosis
- Being tested
- Vantobra (tobramycin), TOBI (tobramycin)
- Keywords
- Bioequivalence, AUC, Cmax
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vantobra (tobramycin)Drug
Inhalation
TOBI (tobramycin)Drug
Inhalation
| Study group | Role | What they receive |
|---|---|---|
| Vantobra; Treatment A | Experimental | Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution Receives: Drug: Vantobra (tobramycin) |
| TOBI; Treatment B | Active comparator | TOBI, 300 mg tobramycin/5 mL nebulizer solution Receives: Drug: TOBI (tobramycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
Plasma AUClast of tobramycin
Measured: Day 1 and Day 7
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
Plasma Cmax of tobramycin
Measured: Day 1 and Day 7
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
tmax of tobramycin
Measured: Day 1 and Day 7
Secondary outcomes (1)
Number of Adverse Events during the trial period
Adverse events
Measured: Adverse Events during the study period of max. 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pari Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolgang Timmer, MD, Principal investigator, Inamed GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953367
- Sponsor's protocol ID
- 12012.102
- Status last verified
- Apr 2014
- First submitted
- 4 Sep 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01953367
- Acronym / sponsor ID
- 12012.102
- Conditions
- Cystic Fibrosis
- Keywords
- Bioequivalence, AUC, Cmax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Pari Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Oct 2013 (estimated)
- 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 will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.
Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vantobra; Treatment A | Experimental | Drug: Vantobra (tobramycin)Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution |
| TOBI; Treatment B | Active comparator | Drug: TOBI (tobramycin)TOBI, 300 mg tobramycin/5 mL nebulizer solution |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female healthy subjects of any ethnic origin
- Aged between 18 and 50 years of age
- Body weight of ≥50 kg and body mass index (BMI) between 18.5 and 29 kg/m2
- FEV1 > 90% of predicted
- Able to demonstrate correct inhaler use
Key exclusion criteria (9 listed)
- History of clinically relevant allergies or idiosyncrasies to tobramycin or any other inactive ingredient(s) of the IMP
- Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis.
- Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric or other diseases at screening
- Surgery of the gastrointestinal or respiratory tract which might interfere with drug absorption
- History of malignancy within the past 5 years
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 |
|---|---|---|
| Vantobra (tobramycin)Inhalation | Drug | Vantobra; Treatment A |
| TOBI (tobramycin)Inhalation | Drug | TOBI; Treatment B |
Primary outcome
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
Time frame: Day 1 and Day 7
Plasma AUClast of tobramycin
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
Time frame: Day 1 and Day 7
Plasma Cmax of tobramycin
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
Time frame: Day 1 and Day 7
tmax of tobramycin
1 secondary outcome
Number of Adverse Events during the trial period
Time frame: Adverse Events during the study period of max. 17 days
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 25 Apr 2014.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Wolgang Timmer, MD principal investigator
Inamed GmbH
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 Vantobra (tobramycin) and TOBI (tobramycin) in people with Cystic Fibrosis, run by Pari Pharma GmbH at 1 site in Germany.
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 6 inclusion and 9 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 25 Apr 2014. 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 Germany. 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?
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects (time frame: Day 1 and Day 7). The study lists 3 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 25 Apr 2014.