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Trial record 52 of 333 for:    DABIGATRAN

Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02171481
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 establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and polymorph II

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran etexilate polymorph II Drug: Dabigatran etexilate polymorph I Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2008
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dabigatran etexilate polymorph II Drug: Dabigatran etexilate polymorph II
Active Comparator: Dabigatran etexilate polymorph I Drug: Dabigatran etexilate polymorph I



Primary Outcome Measures :
  1. 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 ]
  2. Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax) [ Time Frame: Up to 72 hours after drug administration ]

Secondary Outcome Measures :
  1. 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 ]
  2. Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax) [ Time Frame: Up to 72 hours after drug administration ]
  3. 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 ]
  4. 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 ]
  5. Time from dosing to the maximum concentration of the analyte in plasma (tmax) [ Time Frame: Up to 72 hours after drug administration ]
  6. Terminal rate constant in plasma (λz) [ Time Frame: Up to 72 hours after drug administration ]
  7. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: Up to 72 hours after drug administration ]
  8. Mean residence time of the analyte in the body after oral administration (MRTpo) [ Time Frame: Up to 72 hours after drug administration ]
  9. Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) [ Time Frame: Up to 72 hours after drug administration ]
  10. Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F ) [ Time Frame: Up to 72 hours after drug administration ]
  11. Change from baseline in physical examination [ Time Frame: Baseline, day 68 ]
  12. Change from baseline in vital signs (blood pressure, pulse rate) [ Time Frame: Baseline, day 68 ]
  13. Change from baseline in 12-lead electrocardiogram [ Time Frame: Baseline, day 68 ]
  14. Change from baseline in clinical laboratory tests [ Time Frame: Baseline, day 68 ]
  15. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to day 68 ]
  16. Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) [ Time Frame: Day 68 ]


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ≥60 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 for men and more than 40 g/day for women)
  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
  17. Planned surgeries within four weeks following the end-of study examination
  18. Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, coumarin etc. within 10 days prior to administration
  19. 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)

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171481     History of Changes
Other Study ID Numbers: 1160.66
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