Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of Dabigatran Etexilate With or Without Amiodarone as Single Dose in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Amiodarone; Drug: Dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02171026

1160.57

Details and patient eligibility

About

Investigation of the bioavailability, safety and tolerability of dabigatran with and without concomitant administration of amiodarone and the bioavailability of amiodarone and desethylamiodarone after administration of a single dose of amiodarone with and without dabigatran

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy males and females according to the following criteria:

1. Based upon a complete medical history, including the physical examination, vital signs (BP, pulse rate (PR)), 12-lead ECG, clinical laboratory tests
2. Aged >=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 according to GCP and 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 or acute blood coagulation defect
4. Diseases of the central nervous system, such as epilepsy; 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 study 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 study
9. Use of drugs, which might have reasonably influenced the results of the study based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the study
10. Participation in another study with an investigational drug within two months prior to administration or during the study
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 study
14. Excessive physical activities; within one week prior to administration or during the study
15. Any laboratory value outside the reference range that was of clinical relevance
16. Inability to comply with dietary regimen of study centre
17. Females of child bearing potential who were pregnant, breast feeding or who were either not surgically sterile or were sexually active and not using an acceptable, i.e. highly effective with a Pearl index >1%, 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 18.) Male subjects had to 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. Acceptable methods of contraception comprised barrier contraception and a medically accepted contraceptive method for the female partner (intrauterine device with spermicide, hormonal contraceptive since at least two month).

19.) Abnormal thyroid stimulating hormone (TSH) at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Dabigatran etexilate + Amiodarone

Experimental group

Treatment:

Drug: Dabigatran etexilate

Drug: Amiodarone

Amiodarone

Active Comparator group

Treatment:

Drug: Amiodarone