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To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as capsule in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate pellets | Experimental |
| |
| Dabigatran etexilate powder | Experimental |
| |
| Dabigatran etexilate capsule | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate pellets | Drug |
| ||
| Dabigatran etexilate powder |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf for Total Dabigatran | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| AUC0-inf for Free Dabigatran | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Cmax for Total Dabigatran | Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Cmax for Free Dabigatran | Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz for Total Dabigatran | 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) for total dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
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 could reasonably influence the results of the trial (especially unspecific inducing agents like St. John´s wort (Hypericum perforatum) or that prolong the QT/QTc interval 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
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on trial days
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 was of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for Torsade de Pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
For female subjects:
Intake of medication, which influences the blood clotting, i.e. acetylsalicylic acid, oral vitamin K antagonists etc.
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| ID | Title | Description |
|---|---|---|
| FG000 | A/B/C | Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in Period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution. Treatments were separated by washout period of at least 7 days after drug administration. |
| FG001 | A/C/B | Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject. Treatments were separated by washout period of at least 7 days after drug administration. |
| FG002 | B/A/C | Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution. Treatments were separated by washout period of at least 7 days after drug administration. |
| FG003 | B/C/A | Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water. Treatments were separated by washout period of at least 7 days after drug administration. |
| FG004 | C/A/B | Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject. Treatments were separated by washout period of at least 7 days after drug administration. |
| FG005 | C/B/A | Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in Period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water. Treatments were separated by washout period of at least 7 days after drug administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment. This set was used for safety analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This study is open-label, single dose, randomised, three-way crossover design having 3 treatment periods ie., Dabigatran etexilate 150 mg formulation capsule: Reference (A), Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) and Dabigatran etexilate 150 mg formulation powder: Test 2 (C) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-inf for Total Dabigatran | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran. | PK-Per protocol set (PK-PPS): This subject set included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations with respect to the evaluation of relative bioavailability and who did not vomit at or before 2 times the median tmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng(nanogram)*h(hour)/mL(milliliter) | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
|
From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran Etexilate 150 mg Capsule: Reference (A) | Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Drug |
|
| Dabigatran etexilate capsule | Drug |
|
| AUC0-tz for Free Dabigatran | 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) for free dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Tmax for Total Dabigatran | Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Tmax for Free Dabigatran | Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| λz for Total Dabigatran | Terminal rate constant in plasma (λz) for total dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| λz for Free Dabigatran | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| t1/2 for Total Dabigatran | Terminal half-life of the analyte in plasma (t1/2) for total dabigatran | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| t1/2 for Free Dabigatran | Terminal half-life of the analyte in plasma (t1/2) for free dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| MRTpo for Total Dabigatran | Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| MRTpo for Free Dabigatran | Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| CL/F for Total Dabigatran | Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| CL/F for Free Dabigatran | Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Vz/F for Total Dabigatran | Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Vz/F for Free Dabigatran | Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran. | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
| Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests. | Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events. There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests. | From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days. |
| Percentage of Participants With Drug-related Adverse Events | Percentage of participants with investigator defined drug-releated Adverse events. | From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days. |
| Assessment of Tolerability by Investigator. | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad. | From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Dabigatran Etexilate 150 mg Pellets: Test 1 (B) | Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject. |
| OG002 | Dabigatran Etexilate 150 mg Powder: Test 2 (C) | Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours. |
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| Primary | AUC0-inf for Free Dabigatran | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Primary | Cmax for Total Dabigatran | Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Primary | Cmax for Free Dabigatran | Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | AUC0-tz for Total Dabigatran | 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) for total dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | AUC0-tz for Free Dabigatran | 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) for free dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | Tmax for Total Dabigatran | Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran | pharmacokinetic per-protocol set | Posted | Median | Full Range | hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | Tmax for Free Dabigatran | Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran | pharmacokinetic per-protocol set | Posted | Median | Full Range | hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | λz for Total Dabigatran | Terminal rate constant in plasma (λz) for total dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | λz for Free Dabigatran | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | t1/2 for Total Dabigatran | Terminal half-life of the analyte in plasma (t1/2) for total dabigatran | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | t1/2 for Free Dabigatran | Terminal half-life of the analyte in plasma (t1/2) for free dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | MRTpo for Total Dabigatran | Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | MRTpo for Free Dabigatran | Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | CL/F for Total Dabigatran | Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | mL (milliliter)/min (minute) | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | CL/F for Free Dabigatran | Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | mL (milliliter)/min (minute) | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | Vz/F for Total Dabigatran | Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | Vz/F for Free Dabigatran | Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran. | pharmacokinetic per-protocol set | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | -0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration. |
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| Secondary | Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests. | Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events. There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests. | Treated Set | Posted | Number | Percentage of participants | From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days. |
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| Secondary | Percentage of Participants With Drug-related Adverse Events | Percentage of participants with investigator defined drug-releated Adverse events. | Treated set | Posted | Number | Percentage of participants | From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days. |
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| Secondary | Assessment of Tolerability by Investigator. | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad. | Treated Set | Posted | Number | Percentage of Participants | From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days. |
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| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Dabigatran Etexilate 150 mg Pellets: Test 1 (B) | Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject. | 0 | 30 | 7 | 30 |
| EG002 | Dabigatran Etexilate 150 mg Powder: Test 2 (C) | Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours. | 0 | 30 | 8 | 30 |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Superiority or Other |
| An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Ratio of adjusted geometric means in % | 158.12 | Standard Error of the Mean | 46.7 | 2-Sided | 90 | 130.052 | 192.255 | Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV. | Superiority or Other |
| Superiority or Other |
| An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Ratio of adjusted geometric means in % | 166.59 | Standard Error of the Mean | 54.3 | 2-Sided | 90 | 133.221 | 208.326 | Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV. | Superiority or Other |
| Superiority or Other |
| An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Ratio of adjusted geometric means in % | 166.83 | Standard Error of the Mean | 52.6 | 2-Sided | 90 | 134.25 | 207.328 | Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV). | Superiority or Other |
| Superiority or Other |
| An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Ratio of adjusted geometric means in % | 160.74 | Standard Error of the Mean | 52 | 2-Sided | 90 | 129.633 | 199.306 | Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV. | Superiority or Other |
| Superiority or Other |
| An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Ratio of adjusted geometric means in % | 164.01 | Standard Error of the Mean | 51.7 | 2-Sided | 90 | 132.421 | 203.14 | Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV. | Superiority or Other |
| Title | Measurements |
|---|---|
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| Not satisfactory |
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| Bad |
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| Not assessable |
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