Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride

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: Healthy
• Intervention / Treatment: Drug: Mucosolvan ® adult syrup; Drug: Ambroxol hydrochloride soft pastille

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mucosolvan ® adult syrup	Drug: Mucosolvan ® adult syrup
Experimental: Ambroxol hydrochloride soft pastille	Drug: Ambroxol hydrochloride soft pastille

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	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	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

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

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: Respiratory System Agents; Expectorants; Ambroxol
• Other Study ID Numbers: 18.509