- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02191709
Relative Bioavailability of Dextromethorphan Syrup in Comparison to Dextromethorphan Soft Pastilles in Healthy Male and Female Subjects
July 14, 2014 updated by: Boehringer Ingelheim
A Phase I, Single Dose, Controlled Two-way Crossover Study to Evaluate the Relative Bioavailability of Orally Administered Dextromethorphan Syrup (21 mg Dextromethorphan Hydrobromide Monohydrate) in Comparison to Dextromethorphan Soft Pastilles (21 mg Dextromethorphan Hydrobromide Monohydrate) in Healthy Male and Female Subjects Who Are Extensive Metabolisers for Cytochrom P450 (CYP) 2D6
Study to investigate the relative bioavailability of orally administered dextromethorphan syrup in comparison to dextromethorphan (DMP) soft pastilles in healthy male and female subjects who are extensive metabolisers for CYP 2D6
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Age ≥18 and Age ≤55 years
- BMI ≥18.5 and BMI ≤30 kg/m2 (Body Mass Index)
- Extensive metabolisers for CYP 2D6
- 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
- Surgery of the gastrointestinal tract (except appendectomy)
- 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 drug or its excipients)
- 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 or which prolong the QT/QTc interval 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 one month prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- 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 trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for TdP (Torsades de points) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
For female subjects:
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test
- No adequate contraception in women of childbearing potential during the study, i.e. sterilization, intrauterine device, hormonal contraception
- Lactation period
Exclusion criteria specific for this study:
- Use of drugs that inhibit or induce cytochrome P 450 enzymes, especially CYP 2D6, within 30 days prior to first administration of the study medication or during the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dextromethorphan syrup
Bisoltussin® Syrup
|
|
Active Comparator: Dextromethorphan soft pastilles
Silomat® DMP soft pastilles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) - for dextromethorphan and dextrorphan (total and free)
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
Cmax (maximum measured concentration of the analyte in plasma) - for dextromethorphan and dextrorphan (total and free)
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
tmax (time from dosing to the maximum measured concentration of the analyte in plasma) - for dextromethorphan and dextrorphan (total and free)
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
%AUCtz-∞ (percentage of the AUC0-∞ that is obtained by extrapolation) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
λz (terminal rate constant in plasma) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
t1/2 (terminal half-life of the analyte in plasma) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
MRTpo (mean residence time of the analyte in the body after oral administration) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
CL/F (apparent clearance of the analyte in the plasma after oral administration) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose) - all analytes
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) - 3-hydroxy-morphinan (total and free) and 3- methoxy-morphinan
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
Cmax (maximum measured concentration of the analyte in plasma) - 3-hydroxy-morphinan (total and free) and 3- methoxy-morphinan
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
tmax (time from dosing to the maximum measured concentration of the analyte in plasma) - 3-hydroxy-morphinan (total and free) and 3- methoxy-morphinan
Time Frame: predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 32 hours after drug administration
|
Number of patients with adverse events
Time Frame: up to 53 days
|
up to 53 days
|
Number of patients with abnormal changes in laboratory parameters
Time Frame: Screening, 14 days after the end of last treatment period
|
Screening, 14 days after the end of last treatment period
|
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) (including QT interval and heart rate corrected QTcF and QTcB)
Time Frame: Screening, Day 1, 14 days after the end of last treatment period
|
Screening, Day 1, 14 days after the end of last treatment period
|
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time Frame: Screening, Day 1, 14 days after the end of last treatment period
|
Screening, Day 1, 14 days after the end of last treatment period
|
Assessment of tolerability on a 4-point scale
Time Frame: Day 2 of each treatment period
|
Day 2 of each treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
July 14, 2014
First Submitted That Met QC Criteria
July 14, 2014
First Posted (Estimate)
July 16, 2014
Study Record Updates
Last Update Posted (Estimate)
July 16, 2014
Last Update Submitted That Met QC Criteria
July 14, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1134.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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