Healthy
Conditions
Brief summary
To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I
Interventions
DRUGDabigatran polymorph I (≈ 83%) and polymorph II (≈17%)
DRUGDabigatran polymorph I
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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 2. Age ≥65 and ≤85 years 3. BMI ≥18.5 and BMI ≤32.0 kg/m2 (Body Mass Index) 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria
1. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 2. Clinically relevant surgery of gastrointestinal tract 3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 4. Any relevant bleeding history 5. History of relevant orthostatic hypotension, fainting spells or blackouts 6. Chronic or relevant acute infections 7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator 8. 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 9. 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 10. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial 11. Alcohol abuse (more than 60 g/day) 12. Drug abuse 13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 14. Excessive physical activities (within one week prior to administration or during the trial) 15. Any laboratory value outside the reference range that is of clinical relevance 16. Inability to comply with dietary regimen of study centre
Design outcomes
Primary
| 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-∞) | Up to 72 hours after drug administration |
| Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax) | Up to 72 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| 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) | 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 (AUCt1-t2) | t1 = 0 and t2 = 24, 48, 72 hours after drug administration |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | Up to 72 hours after drug administration |
| Terminal rate constant in plasma (λz) | Up to 72 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | Up to 72 hours after drug administration |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | Up to 72 hours after drug administration |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F ) | Up to 72 hours after drug administration |
| Area under the concentration-time curve of free BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 72 hours after drug administration |
| Change from baseline in physical examination | Baseline, day 73 |
| Change from baseline in vital signs (blood pressure, pulse rate) | Baseline, day 73 |
| Change from baseline in 12-lead ECG (electrocardiogram) | Baseline, day 73 |
| Change from baseline in clinical laboratory tests | Baseline, day 73 |
| Number of Participants with Serious and Non-Serious Adverse Events | Up to day 73 |
| Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) | Day 73 |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | Up to 72 hours after drug administration |
| Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax) | Up to 72 hours after drug administration |
Outcome results
None listed