- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02171481
Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers
June 20, 2014 updated by: Boehringer Ingelheim
Bioequivalence of Two Different Polymorphs of 150 mg Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers (Double-blind, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)
To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
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
60 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
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 (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥60 and ≤85 years
- BMI ≥18.5 and BMI ≤32.0 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion Criteria:
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Clinically relevant surgery of gastrointestinal tract
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Any relevant bleeding history
- 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 four weeks prior to administration or during the trial
- Alcohol abuse (more than 60 g/day for men and more than 40 g/day for women)
- 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
- Planned surgeries within four weeks following the end-of study examination
- Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, coumarin etc. within 10 days prior to administration
- Male subjects who do not agree to minimise the risk of female partners becoming pregnant from the first dosing day until the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dabigatran etexilate polymorph II
|
|
ACTIVE_COMPARATOR: Dabigatran etexilate polymorph I
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of free BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
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 (AUC0-tz)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 with t1 = 0 and t2 = 24, 48, 72 hours (AUCt1-t2)
Time Frame: 24, 48 and 72 hours after drug administration
|
24, 48 and 72 hours after drug administration
|
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Terminal rate constant in plasma (λz)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F )
Time Frame: Up to 72 hours after drug administration
|
Up to 72 hours after drug administration
|
Change from baseline in physical examination
Time Frame: Baseline, day 68
|
Baseline, day 68
|
Change from baseline in vital signs (blood pressure, pulse rate)
Time Frame: Baseline, day 68
|
Baseline, day 68
|
Change from baseline in 12-lead electrocardiogram
Time Frame: Baseline, day 68
|
Baseline, day 68
|
Change from baseline in clinical laboratory tests
Time Frame: Baseline, day 68
|
Baseline, day 68
|
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: up to day 68
|
up to day 68
|
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time Frame: Day 68
|
Day 68
|
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
May 1, 2008
Primary Completion (ACTUAL)
August 1, 2008
Study Registration Dates
First Submitted
June 20, 2014
First Submitted That Met QC Criteria
June 20, 2014
First Posted (ESTIMATE)
June 24, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
June 24, 2014
Last Update Submitted That Met QC Criteria
June 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1160.66
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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