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

NCT ID: NCT02044367

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-04-30

Brief 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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test 1 (Treatment A)

multiple dose of dabigatran

Group Type: EXPERIMENTAL

Dabigatran etexilate

Intervention Type: DRUG

Pellets (multiple dose of dabigatran)

Test 2 (Treatment B)

multiple dose of dabigatran

Group Type: EXPERIMENTAL

Dabigatran etexilate

Intervention Type: DRUG

Granules resolved in reconstitution solution (multiple dose of dabigatran)

Reference

multiple dose of dabigatran

Group Type: EXPERIMENTAL

Dabigatran etexilate

Intervention Type: DRUG

Hard capsule (multiple dose of dabigatran)

Interventions

Dabigatran etexilate

Pellets (multiple dose of dabigatran)

Intervention Type: DRUG

Dabigatran etexilate

Granules resolved in reconstitution solution (multiple dose of dabigatran)

Intervention Type: DRUG

Dabigatran etexilate

Hard capsule (multiple dose of dabigatran)

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1160.194.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Countries

Germany

Other Identifiers

2013-002498-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.194

Identifier Type: -

Identifier Source: org_study_id