Phase 1 Completed N=54 Randomized Treatment

Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers

Healthy

Source: ClinicalTrials.gov NCT02044367 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcomePrimary: Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran. — 1220; 1160; 893 ng∙h/mL

Summary

To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.	1220; 1160; 893	—
PRIMARY Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.	191; 184; 131	—
SECONDARY Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.	1000; 958; 727	—
SECONDARY Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.	157; 154; 106	—
SECONDARY Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.	37; 29; 9; 17; 7; 7	—
SECONDARY Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.	2; 0; 20; 15; 18; 17	—

Eligibility Criteria

Inclusion criteria

Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
Age 18 to 55 years (incl.)
Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.
Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:
Hemorrhagic disorders or bleeding diathesis
Occult blood in faeces or haematuria
Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
History of arteriovenous malformation or aneurysm
History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
Anemia at screening
Thrombocytopenia (platelet count less than 100/nL)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02044367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.