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Trial record 54 of 333 for:    DABIGATRAN

Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02171013
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%) Drug: Dabigatran 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 Drug Product Batches of 150 mg of 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 Study)
Study Start Date : April 2006
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dabigatran etexilate batch A Drug: Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)
Experimental: Dabigatran etexilate batch B Drug: Dabigatran 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 (AUCt1-t2) [ Time Frame: t1 = 0 and t2 = 24, 48, 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 73 ]
  12. Change from baseline in vital signs (blood pressure, pulse rate) [ Time Frame: Baseline, day 73 ]
  13. Change from baseline in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline, day 73 ]
  14. Change from baseline in clinical laboratory tests [ Time Frame: Baseline, day 73 ]
  15. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to day 73 ]
  16. Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) [ Time Frame: Day 73 ]


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Ages Eligible for Study:   65 Years to 85 Years   (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 ≥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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171013     History of Changes
Other Study ID Numbers: 1160.56
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 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