HealthyPhase 1NCT02572609

Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride

A Phase 1 study testing Ambroxol hydrochloride soft pastille and Mucosolvan ® adult syrup in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation), manufactured by Bolder Arzneimittel GmbH \& Co. KG to Boehringer Ingelheim compared to ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ambroxol hydrochloride soft pastille and Mucosolvan ® adult syrup
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: No sites listed yet
Study dates: Nov 2011to Dec 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult

Who may be able to join

The volunteer is between 18 and 50 years old, is a man or a woman who is not pregnant and/or in breastfeeding regime, and undertakes to use effective birth control method throughout the study period.
Body mass index higher than or equal to 18.5 and lower than or equal to 29.9 kg/m2.
The volunteer is in good health status and is with no clinically significant diseases, at the discretion of the physician as Medical History, measurements of Blood Pressure, Pulse and Temperature, Physical Examination, Electrocardiogram and complementary Laboratory Tests.
Volunteer able to understand the nature and objective of the study, including the risks and adverse effects, with the intention to cooperate with the investigator and act in accordance with the requirements of the entire trial, which has to be confirmed by signing the Informed Consent Form.

Who cannot join

Volunteer has a known hypersensitivity to study drug or chemically related compounds; or to excipients described in adult syrup and/or soft pastille, for example, sorbitol (fructose).
History or presence of gastrointestinal or liver diseases, or other condition that interferes with the absorption, distribution, excretion or metabolism of the drug.
Use of maintenance therapy with any drug, except contraceptives.
Diseases or health problems
History of liver, renal, pulmonary, gastrointestinal, neurological, hematological, psychiatric, cardiac or allergic disease of any cause that requires pharmacological treatment or is considered to be clinically relevant by the investigator;
Electrocardiographic findings not recommended, at the discretion of the investigator the participation in the study.

Show all 18Show fewer

Additional laboratory test results out of normal values according to the standard of this Potocol, unless they are considered clinically not significant by the investigator.
Tabagism.
Daily intake of more than 5 cups of coffee or tea.
History of alcohol or drug abuse.
Use of regular medication within 2 weeks prior to the initiation of this study, or use of any medication one week before starting this study.
Hospitalization for any reason up to 8 weeks before starting the first treatment period of this study.
Treatment within 3 months prior to this study treatment initiation with any drug that is known to have a well-defined toxic potential in large organs.
Participation in any pharmacokinetic study with more than 300 mL of blood taken or ingested any - study drug within six months preceding the treatment start of this study.
Donation or loss of 450 mL or more of blood within three months preceding the study or who donated more than 1500 mL within 12 months prior to this study treatment initiation.
Pre-Confinement Examination Results
Positive result for urine βHCG test carried out in female volunteers. Other conditions
Any condition that prevents participation in the study as judged by the investigator.

About this study

Conditions: Healthy
Being tested: Ambroxol hydrochloride soft pastille, Mucosolvan ® adult syrup

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ambroxol hydrochloride soft pastilleDrug
Mucosolvan ® adult syrupDrug

Study groups in NCT02572609
Study group	Role	What they receive
Mucosolvan ® adult syrup	Experimental	Not described Receives: Drug: Mucosolvan ® adult syrup
Ambroxol hydrochloride soft pastille	Experimental	Not described Receives: Drug: Ambroxol hydrochloride soft pastille

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum plasma concentration achieved
Measured: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h
AUC0-t
Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ).
Measured: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Dec 2011

First posted9 Oct 2015 (estimated)
Study startNov 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Intervention model: Crossover
Masking: None (open label)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02572609
Sponsor's protocol ID: 18.509
Status last verified: Nov 2015
First submitted: 5 Oct 2015
Last updated: 31 Dec 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride
ClinicalTrials.gov ID: NCT02572609
Acronym / sponsor ID: 18.509
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 9 Oct 2015 (estimated)
Results: Posted 31 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mucosolvan ® adult syrup	Experimental	Drug: Mucosolvan ® adult syrup
Ambroxol hydrochloride soft pastille	Experimental	Drug: Ambroxol hydrochloride soft pastille

Who may qualify

Ages: 18 to 50 years
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

The volunteer is between 18 and 50 years old, is a man or a woman who is not pregnant and/or in breastfeeding regime, and undertakes to use effective birth control method throughout the study period.
Body mass index higher than or equal to 18.5 and lower than or equal to 29.9 kg/m2.
The volunteer is in good health status and is with no clinically significant diseases, at the discretion of the physician as Medical History, measurements of Blood Pressure, Pulse and Temperature, Physical Examination, Electrocardiogram and complementary Laboratory Tests.
Volunteer able to understand the nature and objective of the study, including the risks and adverse effects, with the intention to cooperate with the investigator and act in accordance with the requirements of the entire trial, which has to be confirmed by signing the Informed Consent Form.

Key exclusion criteria (18 listed)

Volunteer has a known hypersensitivity to study drug or chemically related compounds; or to excipients described in adult syrup and/or soft pastille, for example, sorbitol (fructose).
History or presence of gastrointestinal or liver diseases, or other condition that interferes with the absorption, distribution, excretion or metabolism of the drug.
Use of maintenance therapy with any drug, except contraceptives.
Diseases or health problems
History of liver, renal, pulmonary, gastrointestinal, neurological, hematological, psychiatric, cardiac or allergic disease of any cause that requires pharmacological treatment or is considered to be clinically relevant 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
Mucosolvan ® adult syrup	Drug	Mucosolvan ® adult syrup

Primary outcome

Cmax
Time frame: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h
Maximum plasma concentration achieved
AUC0-t
Time frame: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h
Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ).

Results and safety

Results posted to the registry on 31 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence: TR	18	18
Sequence: RT	18	18

Primary outcome: Cmax

Time frame: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Mucosolvan ® Adult Syrup n = 18	Ambroxol Hydrochloride Soft Pastille n = 18
Value	31.27 (30.38)	35.50 (28.62)

Mucosolvan ® Adult Syrup vs Ambroxol Hydrochloride Soft Pastille: T/R Ratio: 113.56 (90% CI 106.48 to 121.10), p = 0.0082, Anderson-Hauck procedure

Population analysed: The pharmacokinetic set (PK Set): 36 subjects provided 1 evaluable value of reference product and 1 evaluable value of test product for the primary PK endpoints (Cmax and AUC0-t) without important protocol violations with respect to the statistical evaluation of PK endpoints.

Primary outcome: AUC0-t

Measure	Mucosolvan ® Adult Syrup n = 18	Ambroxol Hydrochloride Soft Pastille n = 18
Value	256.66 (33.36)	307.00 (28.97)

Mucosolvan ® Adult Syrup vs Ambroxol Hydrochloride Soft Pastille: T/R Ratio: 119.61 (90% CI 114.65 to 124.79), p = 0.0438, Anderson-Hauck procedure

Population analysed: PK set

Adverse events

Time frame: From first drug administration until 48 hours after last drug administration, upto 08 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mucosolvan® Adult Syrup	0 of 36 (0%)	0 of 36 (0%)	Not reported
Ambroxol Hydrochloride Soft Pastille	0 of 36 (0%)	0 of 36 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ambroxol hydrochloride soft pastille and Mucosolvan ® adult syrup 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 4 inclusion and 18 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 31 Dec 2015. 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?

Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h). 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?

On the ClinicalTrials.gov record for NCT02572609.

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 31 Dec 2015.