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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Dabigatran etexilate capsules

Drug: Enoxaparin prefilled syringes

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171559

1160.78

Details and patient eligibility

About

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

Enrollment

29 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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
Age ≥18 to ≤55 years
Body mass index (BMI) ≥18.5 to ≤29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
Relevant surgery of gastrointestinal tract
History of any bleeding disorder or acute blood coagulation defect
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
Intake of any medication within 2 weeks of first dosing, especially intake of medication, which influences blood clotting, i.e. acetylsalicylic acid, cumarin etc.
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
Alcohol abuse (more than 60 g/day for males and more than 20 g/day for females)
Drug abuse
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
Participation in another trial with an investigational drug within 2 months prior to trial drug administration or during the trial
Blood donation (more than 100 mL within 4 weeks prior to trial drug administration or during the trial)
Excessive physical activities (within 1 week prior to trial drug administration or during the trial)
Any laboratory value outside the reference range that was of clinical relevance
Inability to comply with dietary regimen of study centre
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days

For female subjects:
Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month after study completion
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)
Lactation period