HealthyPhase 1NCT01423721
Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)
A Phase 1 study testing Bromihexine hydrochloride syrup and Bromihexine hydrochloride granules in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup 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?
- Bromihexine hydrochloride syrup and Bromihexine hydrochloride granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Oct 2011
- 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 male and female volunteers
Who cannot join
- Any relevant deviation from healthy conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of Bromhexine for Oral Administration of 16 mg of Bromhexine Hydrochloride Granules Compared to 16 mg of Bromhexine Hydrochloride Syrup in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Replicate Design Phase I Study With Two Treatments in Four Crossover Periods)
The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup
- Conditions
- Healthy
- Being tested
- Bromihexine hydrochloride syrup, Bromihexine hydrochloride granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromihexine hydrochloride syrupDrug
syrup
Bromihexine hydrochloride granulesDrug
granules
| Study group | Role | What they receive |
|---|---|---|
| Bromihexine hydrochloride granules | Experimental | 16 mg granules Receives: Drug: Bromihexine hydrochloride granules |
| Bromihexine hydrochloride syrup | Experimental | 16 mg syrup Receives: Drug: Bromihexine hydrochloride syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-tz (area under the plasma concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: 48 h
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 48 h
Secondary outcomes (1)
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423721
- Sponsor's protocol ID
- 65.129
- Other IDs
- 2011-002733-19
- Status last verified
- Oct 2013
- First submitted
- 25 Aug 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Bromhexine for Oral Administration of 16 mg of Bromhexine Hydrochloride Granules Compared to 16 mg of Bromhexine Hydrochloride Syrup in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Replicate Design Phase I Study With Two Treatments in Four Crossover Periods)
- ClinicalTrials.gov ID
- NCT01423721
- Acronym / sponsor ID
- 65.129
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- First posted
- 26 Aug 2011 (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.
The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromihexine hydrochloride granules | Experimental | Drug: Bromihexine hydrochloride granules16 mg granules |
| Bromihexine hydrochloride syrup | Experimental | Drug: Bromihexine hydrochloride syrup16 mg syrup |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female volunteers
Key exclusion criteria (1 listed)
- Any relevant deviation from healthy conditions
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 |
|---|---|---|
| Bromihexine hydrochloride syrupsyrup | Drug | Bromihexine hydrochloride syrup |
| Bromihexine hydrochloride granulesgranules | Drug | Bromihexine hydrochloride granules |
Primary outcome
AUC0-tz (area under the plasma concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: 48 h
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 48 h
1 secondary outcome
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)
Time frame: 48 h
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 1 Nov 2013.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 Bromihexine hydrochloride syrup and Bromihexine hydrochloride granules in people with Healthy, run by Boehringer Ingelheim 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 1 inclusion and 1 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 1 Nov 2013. 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?
AUC0-tz (area under the plasma concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) (time frame: 48 h). 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 1 Nov 2013.