Relative Bioavailability of Ambroxol Hydrochloride of Soft Pastilles Compared to Ambroxol Hydrochloride Syrup in Healthy Male and Female Volunteers

NCT02194270 | Completed Phase 1

• 1 other identifier: 18.488
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 30 hours after each drug administration

• Cmax (maximum concentration of the analyte in plasma)

  up to 30 hours after each drug administration

Secondary Outcomes (11)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 30 hours after each drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 30 hours after each drug administration

• λz (terminal rate constant in plasma)

  up to 30 hours after each drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 30 hours after each drug administration

• MRTpo (mean residence time of the analyte in the body after p.o. (oral) administration)

  up to 30 hours after each drug administration

Study Arms (3)

Ambroxol hydrochloride - soft pastille

EXPERIMENTAL

Drug: Ambroxol hydrochloride - soft pastille

Ambroxol hydrochloride - syrup - low dose

ACTIVE COMPARATOR

Drug: Ambroxol hydrochloride - syrup - low dose

Ambroxol hydrochloride - syrup - high dose

ACTIVE COMPARATOR

Drug: Ambroxol hydrochloride - syrup - high dose

Interventions

Ambroxol hydrochloride - soft pastille DRUG

Ambroxol hydrochloride - soft pastille

Ambroxol hydrochloride - syrup - low dose DRUG

Ambroxol hydrochloride - syrup - low dose

Ambroxol hydrochloride - syrup - high dose DRUG

Ambroxol hydrochloride - syrup - high dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥18 and Age ≤55 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of study centre

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: September 1, 2004
• Primary Completion: February 1, 2005
• Last Updated: July 18, 2014

Record last verified: 2014-07