Relative Bioavailability of Ambroxol Hydrochloride Lozenge in Comparison to Ambroxol Hydrochloride Syrup (Mucosolvan®) in Healthy Female and Male Volunteers

July 17, 2014 updated by: Boehringer Ingelheim

An Open Label, Randomised, Two-way Crossover Study in Healthy Female and Male Volunteers to Evaluate the Relative Bioavailability of a 20 mg Ambroxol Hydrochloride Lozenge in Comparison to 30 mg Ambroxol Hydrochloride Syrup (Mucosolvan®)

Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All participants in the study should be healthy males and females
  • Ages range from 18 to 55 years
  • Broca Index of > -20% and < +20 %
  • Prior to admission of study all volunteers will have given their written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation
  • Each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG)
  • Haematopoietic, hepatic and renal function tests will be carried out in the laboratory
  • The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration to the test substance

Exclusion Criteria:

  • Volunteers will be excluded from the study if the results of the medical examination or laboratory test are judged by the clinical investigator to differ significantly from normal clinical values
  • Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic immunological or hormonal disorders
  • Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
  • Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
  • Volunteers with chronic or relevant acute infections
  • Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Volunteers who have taken a drug with a long half-life (>= 24 hours) within one month before enrolment in the study
  • Volunteers who received any other drugs which might influence the results of the trial during the week previous to the start of the study
  • Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
  • Volunteers who smoke (more than 10 cigarettes or 3 cigars or 3 pipes/day)
  • Volunteers who are not able to refrain from smoking on study days
  • Volunteers who drink more than 60 g of alcohol per day
  • Volunteers who are dependent on drugs
  • Volunteers who have participated in excessive physical activities (e.g. competitive sports) within the last week before the study
  • Volunteers who have donated blood (> 100 ml) within the last 4 weeks prior to administration

For female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. sterilization, Intrauterine Devices (IUD), oral contraceptives
  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ambroxol hydrochloride - lozenge
Drug: Ambroxol hydrochloride - lozenge
Active Comparator: Ambroxol hydrochloride - syrup
Mucosolvan®
Drug: Ambroxol hydrochloride - syrup

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax (Maximum observed concentration of the analyte in plasma)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
AUC0-t (Total area under the plasma concentration-time curve from time of administration to the last quantifiable drug concentration)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
λz (Terminal rate constant in Plasma)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
t½ (Terminal half-life of the analyte in plasma)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
MRTtot (Total mean residence time )
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time Frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
Number of patients with adverse events
Time Frame: up to 26 days
up to 26 days
Number of patients with clinically significant changes in vital signs
Time Frame: up to 26 days
up to 26 days
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 26 days
up to 26 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18.479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings