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Single and Multiple Oral Doses of Dabigatran Etexilate in Healthy Chinese Subjects

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ClinicalTrials.gov Identifier: NCT02171572
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of the current study is to investigate safety, tolerability and, pharmacokinetics of dabigatran etexilate following oral administration of single and multiple oral doses (110mg, 150 mg b.i.d., 7 days) in healthy Chinese subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran etexilate low Drug: Dabigatran etexilate high Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics Study After Single and Multiple Oral Doses of Dabigatran Etexilate Capsule (110mg,150 mg b.i.d., 7 Days) in Healthy Chinese Subjects (Open Label Study)
Study Start Date : October 2009
Actual Primary Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dabigatran etexilate low Drug: Dabigatran etexilate low
Experimental: Dabigatran etexilate high Drug: Dabigatran etexilate high



Primary Outcome Measures :
  1. Changes in physical examination [ Time Frame: Day 1 and 14 ]
  2. Changes in vital signs [ Time Frame: Day 1 to 14 ]
  3. Changes in 12-lead electrocardiogram (ECG) [ Time Frame: Day 1, Day 4-10, day 14 ]
  4. Changes from baseline in laboratory examinations [ Time Frame: Day 1, 2, 4, 7, 11, 14 ]
  5. Occurrence of adverse events [ Time Frame: up to 7 days after last drug intake ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  2. tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  3. AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the single dose on Day 1) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  4. AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  5. AUC0-∞ (amount of analyte that is eliminated in area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  6. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  7. λz (terminal rate constant in plasma) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  8. t1/2, (terminal half-life of the analyte in plasma) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  9. MRTpo, (mean residence time of the analyte in the body after oral administration) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  10. CL/F, (apparent clearance of the analyte in plasma following extravascular administration) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  11. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after single dose of study drug ]
  12. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  13. tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  14. Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  15. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  16. λz,ss (terminal rate constant in plasma at steady state) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  17. t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  18. MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  19. CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  20. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  21. RA,Cmax, (calculated as Cmax,ss/Cmax) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  22. RA,AUC, (calculated as AUCτ,ss/AUCτ,1) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]
  23. linearity index (LI) [ Time Frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours after last multiple dose of study drug ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR and body temperature), 12-lead ECG, clinical laboratory tests

    • No finding of clinical relevance.
    • No evidence of a clinically relevant concomitant disease.
  • Age: ≥18 and ≤45 years.
  • Body Mass Index (BMI): ≥18 and <25 kg/m2.
  • Signed and dated written informed consent prior to admission to the trial in accordance with Chinese GCP.

Exclusion Criteria:

  • Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
  • Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination.
  • Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders.
  • History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts.
  • Chronic or relevant acute infections.
  • History of

    • allergy/hypersensitivity (including drug allergy) which was deemed relevant to the safety assessment as judged by the investigator (excluding asymptomatic seasonal rhinitis/hay fever)
    • any bleeding disorder including prolonged or habitual bleeding
    • other hematologic diseases.
    • cerebral bleeding (e.g. after a car accident).
    • concussions (head trauma resulting in injuring to brain) with or without loss of consciousness.
  • Intake of drugs with a long half-life (> 24 hours) within at least 1 month or less than 10 half-lives, whichever was shorter, of the respective drug prior to administration or during the trial.
  • Use of aspirin (including over-the-counter medications), antiplatelet agents like ticlopidine or dipyridamole, chronic administration of non-steroidal anti-inflammatory drugs (NSAID), coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 14 days prior to administration up to end-of-study examination.
  • Participation in another trial with an investigational drug within 3 months prior to administration up to end-of-study examination.
  • Smoker (>10 cigarettes/day or inability to refrain from smoking during the trial).
  • Alcohol abuse (more than 60 g/day; confirmed by interview).
  • Drug abuse (confirmed by interview).
  • Blood donation (more than 100 mL from 3 months prior to screening and any blood donation from screening up to end-of-study examination).
  • Excessive physical activities (within 7 days prior to the first drug administration up to end-of-study examination).
  • Any laboratory value outside the reference range that is of clinical relevance.
  • Known hypersensitivity to the investigational drug or its excipients.
  • Subject who was judged ineligible by the investigator or the sub-investigator.
  • History of any familial bleeding disorder.
  • Thrombocytes < 100×109 .
  • Pregnant female subjects.

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02171572     History of Changes
Other Study ID Numbers: 1160.81
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