Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers

NCT ID: NCT02171559

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31

Brief Summary

To investigate the relative bioavailability and the pharmacodynamics of dabigatran after switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone

Conditions

Healthy

Study Design

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

Study Groups

Dabigatran etexilate capsules after enoxaparin ampoules

Group Type: EXPERIMENTAL

Enoxaparin prefilled syringes

Intervention Type: DRUG

Dabigatran etexilate capsules

Intervention Type: DRUG

Dabigatran etexilate capsules without enoxaparin

Group Type: ACTIVE_COMPARATOR

Dabigatran etexilate capsules

Intervention Type: DRUG

Interventions

Enoxaparin prefilled syringes

Intervention Type: DRUG

Dabigatran etexilate capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects were healthy males and females based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests

2. Age ≥18 to ≤55 years

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

4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria

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

2. Relevant surgery of gastrointestinal tract

3. History of any bleeding disorder 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 was deemed relevant to the trial as judged by the investigator

8. Intake of any medication within 2 weeks of first dosing, especially intake of medication, which influences blood clotting, i.e. acetylsalicylic acid, cumarin etc.

9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 4 weeks prior to administration or during the trial

10. Alcohol abuse (more than 60 g/day for males and more than 20 g/day for females)

11. Drug abuse

12. Intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's wort within 5 days of first dosing

13. Participation in another trial with an investigational drug within 2 months prior to trial drug administration or during the trial

14. Blood donation (more than 100 mL within 4 weeks prior to trial drug administration or during the trial)

15. Excessive physical activities (within 1 week prior to trial drug administration or during the trial)

16. Any laboratory value outside the reference range that was of clinical relevance

17. Inability to comply with dietary regimen of study centre

18. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)

19. Inability to refrain from smoking on trial days

For female subjects:

20. Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month after study completion

21. No adequate contraception during the study and within 1 month after study completion such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who did not have a vasectomised partner, were not sexually abstinent or surgically sterile, were asked to additionally use a barrier contraception method (e.g. condom, diaphragm with spermicide)

22. Lactation period

• 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

1160.78

Identifier Type: -

Identifier Source: org_study_id