Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of Dabigatran Etexilate Capsule in Healthy Subjects

Recruitment & Eligibility

Inclusion Criteria

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
Age ≥18 and ≤55 years
Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

Exclusion Criteria

Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Relevant surgery of gastrointestinal tract
History of any bleeding disorder or acute blood coagulation defect
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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
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
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Alcohol abuse (more than 60 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of study centre

Study & Design

Arm && Interventions

Group	Intervention	Description
Dabigatran etexilate low dose	Placebo	-
Dabigatran etexilate medium dose	Placebo	-
Dabigatran etexilate high dose	Dabigatran etexilate high dose	-
Dabigatran etexilate high dose	Placebo	-
Dabigatran etexilate low dose	Dabigatran etexilate low dose	-
Dabigatran etexilate medium dose	Dabigatran etexilate medium dose	-

Primary Outcome Measures

Name	Time	Method
Frequency [N (%)] of subjects with adverse events	up to 18 days

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of free and total BIBR 953 ZW in plasma)	up to 72 hours after administration
tmax (time from dosing to maximum measured concentration)	up to 72 hours after administration
AUC0-∞ (area under the concentration-time curve of free and total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity)	up to 72 hours after administration
λz (terminal rate constant in plasma)	up to 72 hours after administration
t1/2 (terminal half-life of the analyte in plasma)	up to 72 hours after administration
MRTpo (mean residence time of the analyte in the body after oral administration)	up to 72 hours after administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)	up to 72 hours after administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	up to 72 hours after administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)	up to 72 hours after administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)	up to 72 hours after administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)	up to 72 hours after administration

Recruitment & Eligibility