Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers

NCT ID: NCT02171507

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31

Brief Summary

To investigate the relative bioavailability of dabigatran with and without concomitant administration of diclofenac and the relative bioavailability of diclofenac with and without concomitant administration of dabigatran etexilate

Conditions

Healthy

Study Design

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

Study Groups

Dabigatran etexilate

Group Type: ACTIVE_COMPARATOR

Dabigatran etexilate

Intervention Type: DRUG

Diclofenac

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Dabigatran etexilate + diclofenac

Group Type: EXPERIMENTAL

Dabigatran etexilate

Intervention Type: DRUG

Diclofenac

Intervention Type: DRUG

Interventions

Dabigatran etexilate

Intervention Type: DRUG

Diclofenac

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, clinical laboratory tests

2. Age ≥18 and ≤55 years

3. Body mass index (BMI) ≥18.5 and BMI ≤29.9 kg/m2

4. 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

1. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

2. Relevant surgery of gastrointestinal tract

3. History of any bleeding disorder including history of gastrointestinal erosions and ulcer or acute blood coagulation defect

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

5. History of relevant orthostatic hypotension, fainting spells or blackouts

6. Chronic or relevant acute infections

7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the objectives of the trial as judged by the investigator

8. 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

9. 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

10. Participation in another trial with an investigational drug within two months prior to administration or during the trial

11. Alcohol abuse (more than 60 g/day)

12. Drug abuse

13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

14. Excessive physical activities (within one week prior to administration or during the trial)

15. Any laboratory value outside the reference range that is of clinical relevance

16. Subjects with abnormal thrombocyte counts and any relevant deviation in the assessment of platelet function (PFA test) must be excluded

17. Inability to comply with dietary regimen of study centre

18. Females of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile or are sexually active and not using an acceptable form of contraception as either the oral contraceptives since at least two months and the double barrier method, i.e. intrauterine device with spermicide and condom for the male partner

19. Male subjects must agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)

20. Planned surgeries within four weeks following the end-of study examination

21. Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, cumarin etc.

22. The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

23. Vulnerable subjects (e.g. persons kept in detention).

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

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.7

Identifier Type: -

Identifier Source: org_study_id