- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02572609
Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride
November 26, 2015 updated by: Boehringer Ingelheim
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- 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
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- 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.
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
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mucosolvan ® adult syrup
|
|
Experimental: Ambroxol hydrochloride soft pastille
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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).
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 5, 2015
First Submitted That Met QC Criteria
October 8, 2015
First Posted (Estimate)
October 9, 2015
Study Record Updates
Last Update Posted (Estimate)
December 31, 2015
Last Update Submitted That Met QC Criteria
November 26, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18.509
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.
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