Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride
Condition: Healthy
Intervention: Ambroxol hydrochloride soft pastille; Mucosolvan ® adult syrup
Intervention MeSH terms: Ambroxol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Crossover Assignment
Masking: None (Open Label)
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.