Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers

NCT ID: NCT02171520

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31

Brief Summary

The objective was to demonstrate the bioequivalence of capsules made from 2 different drug product batches. The reference batch was representative of the current commercial drug product and of the pivotal Phase III batches. The test batch was the drug product batch intended for future commercial use.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dabigatran etexilate generation I

Group Type: EXPERIMENTAL

Dabigatran etexilate generation I

Intervention Type: DRUG

Dabigatran etexilate generation II

Group Type: ACTIVE_COMPARATOR

Dabigatran etexilate generation II

Intervention Type: DRUG

Interventions

Dabigatran etexilate generation I

Intervention Type: DRUG

Dabigatran etexilate generation II

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 ≥60 and ≤85 years

3. Body mass index (BMI) ≥18.5 and BMI ≤30.0 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. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

2. Clinically relevant surgery of gastrointestinal tract

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

4. Any relevant bleeding history

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 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 four weeks prior to administration or during the trial

11. Alcohol abuse (more than 60 g/day for men and more than 40 g/day for woman)

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 (especially hemoglobin and activated partial thromboplastin time) or positive drug or virus screening

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

17. Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study

18. Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study

19. Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study

20. Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, coumarin etc. within 10 days prior to administration

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

22. Male subjects who do not agree to minimise the risk of female partners becoming pregnant from the first dosing day until 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 months)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1160.70

Identifier Type: -

Identifier Source: org_study_id