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Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02171559
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the relative bioavailability and the pharmacodynamics of dabigatran after switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone

Condition or disease Intervention/treatment Phase
Healthy Drug: Enoxaparin prefilled syringes Drug: Dabigatran etexilate capsules Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability and Pharmacodynamics of Dabigatran After a Single Dose of 220 mg Dabigatran Etexilate and After 40 mg Enoxaparin s.c. for 3 Days Followed by a Single Dose of 220 mg Dabigatran Etexilate in Healthy Male and Female Volunteers (an Open-label, Randomised, Single and Multiple Dose, Two Way Crossover Phase I Study)
Study Start Date : August 2008
Actual Primary Completion Date : September 2008

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Arm Intervention/treatment
Experimental: Dabigatran etexilate capsules after enoxaparin ampoules Drug: Enoxaparin prefilled syringes
Drug: Dabigatran etexilate capsules
Active Comparator: Dabigatran etexilate capsules without enoxaparin Drug: Dabigatran etexilate capsules



Primary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0−∞) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  2. Maximum measured concentration of the analyte in plasma (Cmax ) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  3. Area under the effect-time curve of the analyte in plasma over the time interval from 0 to 48 h after administration (AUEC0−48) after dabigatran alone and after dabigatran following enoxaparin administration [ Time Frame: Up to 48 hours after drug administration ]
  4. Maximum effect ratio to baseline (ERmax) after dabigatran alone and after dabigatran following enoxaparin administration [ Time Frame: Baseline and up to 48 hours after drug administration ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  2. Time from dosing to the maximum concentration of the analyte in plasma (tmax) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  3. Terminal rate constant in plasma (λz) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  4. Terminal half-life of the analyte in plasma (t1/2) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  5. Mean residence time of the analyte in the body after oral administration (MRTpo) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  6. Apparent clearance of the analyte in plasma after extravascular administration (CL/F) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  7. Apparent volume of distribution during the terminal phase λz following an extravascular administration (Vz/F) of dabigatran [ Time Frame: Up to 48 hours after drug administration ]
  8. Anti-FIIa activity for Dabigatran etexilate [ Time Frame: Up to 48 hours after drug administration ]
  9. Anti-FXa/anti-FIIa activity for Enoxaparin [ Time Frame: Up to 48 hours after drug administration ]
  10. Activated partial thromboplastin time (aPTT) for Dabigatran etexilate [ Time Frame: Up to 48 hours after drug administration ]
  11. Ecarin clotting time (ECT) for Dabigatran etexilate [ Time Frame: Up to 48 hours after drug administration ]
  12. Thrombin time (TT) for Dabigatran etexilate [ Time Frame: Up to 48 hours after drug administration ]
  13. Change in vital signs (blood pressure, pulse rate) [ Time Frame: up to day 61 ]
  14. Change in 12-lead electrocardiogram (ECG) [ Time Frame: up to day 61 ]
  15. Change in clinical laboratory tests [ Time Frame: up to day 61 ]
  16. Occurrence of adverse events [ Time Frame: Up to day 61 ]
  17. Assessment of global tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) [ Time Frame: Day 61 ]
  18. Assessment of local tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) [ Time Frame: day 3 of enoxaparin administration ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects were healthy males and females based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
  2. Age ≥18 to ≤55 years
  3. Body mass index (BMI) ≥18.5 to ≤29.9 kg/m2
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  2. Relevant surgery of gastrointestinal tract
  3. History of any bleeding disorder or acute blood coagulation defect
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  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 was deemed relevant to the trial as judged by the investigator
  8. Intake of any medication within 2 weeks of first dosing, especially intake of medication, which influences blood clotting, i.e. acetylsalicylic acid, cumarin etc.
  9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 4 weeks prior to administration or during the trial
  10. Alcohol abuse (more than 60 g/day for males and more than 20 g/day for females)
  11. Drug abuse
  12. Intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's wort within 5 days of first dosing
  13. Participation in another trial with an investigational drug within 2 months prior to trial drug administration or during the trial
  14. Blood donation (more than 100 mL within 4 weeks prior to trial drug administration or during the trial)
  15. Excessive physical activities (within 1 week prior to trial drug administration or during the trial)
  16. Any laboratory value outside the reference range that was of clinical relevance
  17. Inability to comply with dietary regimen of study centre
  18. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  19. Inability to refrain from smoking on trial days

    For female subjects:

  20. Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month after study completion
  21. No adequate contraception during the study and within 1 month after study completion such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who did not have a vasectomised partner, were not sexually abstinent or surgically sterile, were asked to additionally use a barrier contraception method (e.g. condom, diaphragm with spermicide)
  22. Lactation period

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171559     History of Changes
Other Study ID Numbers: 1160.78
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants