Investigation of the Metabolism and Pharmacokinetics of Ambroxol in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [14C]-benzyl ambroxol oral solution

Drug: [14C]-cyclohexane ambroxol oral solution

Drug: Ambroxol lozenge

Study type

Interventional

Funder types

Industry

Identifiers

NCT02194257

18.494

Details and patient eligibility

About

Study to determine the basic pharmacokinetics of ambroxol and [14C]-radioactivity including mass balance, excretion pathways and complete metabolism in healthy male volunteers following administration of a lozenge of 20 mg ambroxol together with an oral solution of 0.4 mg [14C]-ambroxol labelled in two different positions

Enrollment

12 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males 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
Age ≥18 and ≤65 years
Body mass index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
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 relevant allergy/hypersensitivity (including allergy to study drug or its excipients)
Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten 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 ten days prior to administration until after the last sample from Visit 2 is collected
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking during the stay in the trial centre
Alcohol abuse (more than on average two units of alcoholic beverages per day or more than 14 units per week (one unit equals one pint [285 mL] of beer or lager, one glass [125 mL] of wine, 25 mL shot of 40% spirit)).
Drug abuse
Blood donation (more than 100 mL within 60 days prior to study drug administration or during the trial)
Excessive physical activities (within one week prior to administration or during the Trial until follow-up examination)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of study centre
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)

Exclusion criteria specific for this study:

Veins unsuitable for blood sampling
PR interval >220 ms or QRS interval >120 ms
Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or during participation in a medical trial in the previous year
Irregular defecation pattern (less than once per two days)