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Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride

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ClinicalTrials.gov Identifier: NCT02572609
Recruitment Status : Completed
First Posted : October 9, 2015
Results First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ambroxol hydrochloride soft pastille Drug: Mucosolvan ® adult syrup Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride
Study Start Date : November 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mucosolvan ® adult syrup Drug: Mucosolvan ® adult syrup
Experimental: Ambroxol hydrochloride soft pastille Drug: Ambroxol hydrochloride soft pastille


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572609


Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02572609    
Other Study ID Numbers: 18.509
First Posted: October 9, 2015    Key Record Dates
Results First Posted: December 31, 2015
Last Update Posted: December 31, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Ambroxol
Expectorants
Respiratory System Agents