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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02044367

1160.194

2013-002498-23 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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
2. Age 18 to 55 years (incl.)
3. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.

2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease judged clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug

7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

8. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Test 1 (Treatment A)

Experimental group

Description:

multiple dose of dabigatran

Treatment:

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Test 2 (Treatment B)

Experimental group

Description:

multiple dose of dabigatran

Treatment:

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Reference

Experimental group

Description:

multiple dose of dabigatran

Treatment:

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate