HealthyPhase 1NCT02194270
Relative Bioavailability of Ambroxol Hydrochloride of Soft Pastilles Compared to Ambroxol Hydrochloride Syrup in Healthy Male and Female Volunteers
A Phase 1 study testing Ambroxol hydrochloride - soft pastille, Ambroxol hydrochloride - syrup - low dose and Ambroxol hydrochloride - syrup - high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state 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?
- Ambroxol hydrochloride - soft pastille, Ambroxol hydrochloride - syrup - low dose and Ambroxol hydrochloride - syrup - high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Feb 2005
- 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 males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Show all 21Show fewer
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Relative Bioavailability of Ambroxol Hydrochloride Following Oral Administration of Soft Pastilles 15 mg (Test) Compared to 15 mg of Syrup (15mg/5mL, Reference I) and Compared to 15 mg of Syrup (30mg/5mL) (Reference II) in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, 3-way Crossover Study
Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state
- Conditions
- Healthy
- Being tested
- Ambroxol hydrochloride - soft pastille, Ambroxol hydrochloride - syrup - low dose, Ambroxol hydrochloride - syrup - high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambroxol hydrochloride - soft pastilleDrug
Ambroxol hydrochloride - syrup - low doseDrug
Ambroxol hydrochloride - syrup - high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Ambroxol hydrochloride - soft pastille | Experimental | Not described Receives: Drug: Ambroxol hydrochloride - soft pastille |
| Ambroxol hydrochloride - syrup - low dose | Active comparator | Not described Receives: Drug: Ambroxol hydrochloride - syrup - low dose |
| Ambroxol hydrochloride - syrup - high dose | Active comparator | Not described Receives: Drug: Ambroxol hydrochloride - syrup - high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 30 hours after each drug administration
Cmax (maximum concentration of the analyte in plasma)
Measured: up to 30 hours after each drug administration
Secondary outcomes (11)
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 30 hours after each drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 30 hours after each drug administration
λz (terminal rate constant in plasma)
Measured: up to 30 hours after each drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 30 hours after each drug administration
MRTpo (mean residence time of the analyte in the body after p.o. (oral) administration)
Measured: up to 30 hours after each drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 30 hours after each drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 30 hours after each drug administration
Number of patients with adverse events
Measured: up to 40 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to 40 days
Number of patients with clinically significant changes in vital signs (BP (Blood pressure), PR (Pulse rate))
Measured: up to 40 days
Assessment of tolerability by investigator on a 4-point scale
Measured: within 8 days after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startSep 2004
- Primary completionFeb 2005
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194270
- Sponsor's protocol ID
- 18.488
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Ambroxol Hydrochloride Following Oral Administration of Soft Pastilles 15 mg (Test) Compared to 15 mg of Syrup (15mg/5mL, Reference I) and Compared to 15 mg of Syrup (30mg/5mL) (Reference II) in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, 3-way Crossover Study
- ClinicalTrials.gov ID
- NCT02194270
- Acronym / sponsor ID
- 18.488
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Feb 2005 (actual)
- First posted
- 18 Jul 2014 (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.
Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ambroxol hydrochloride - soft pastille | Experimental | Drug: Ambroxol hydrochloride - soft pastille |
| Ambroxol hydrochloride - syrup - low dose | Active comparator | Drug: Ambroxol hydrochloride - syrup - low dose |
| Ambroxol hydrochloride - syrup - high dose | Active comparator | Drug: Ambroxol hydrochloride - syrup - high dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
Key exclusion criteria (21 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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 |
|---|---|---|
| Ambroxol hydrochloride - soft pastille | Drug | Ambroxol hydrochloride - soft pastille |
| Ambroxol hydrochloride - syrup - low dose | Drug | Ambroxol hydrochloride - syrup - low dose |
| Ambroxol hydrochloride - syrup - high dose | Drug | Ambroxol hydrochloride - syrup - high dose |
Primary outcome
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 30 hours after each drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 30 hours after each drug administration
11 secondary outcomes
AUC0-tz (area under the 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: up to 30 hours after each drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 30 hours after each drug administration
λz (terminal rate constant in plasma)
Time frame: up to 30 hours after each drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 30 hours after each drug administration
MRTpo (mean residence time of the analyte in the body after p.o. (oral) administration)
Time frame: up to 30 hours after each drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 30 hours after each drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 30 hours after each drug administration
Number of patients with adverse events
Time frame: up to 40 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 40 days
Number of patients with clinically significant changes in vital signs (BP (Blood pressure), PR (Pulse rate))
Time frame: up to 40 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 8 days after last administration
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 18 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ambroxol hydrochloride - soft pastille, Ambroxol hydrochloride - syrup - low dose and Ambroxol hydrochloride - syrup - high dose in people with Healthy, run by Boehringer Ingelheim.
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 21 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 30 hours after each drug administration). 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 18 Jul 2014.