Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects

NCT ID: NCT02262793

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31

Brief Summary

To investigate the relative bioavailability of telmisartan respectively of dipyridamole after concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).

To investigate the relative bioavailability of dipyridamole respectively of telmisartan administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2) relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone (Reference 2).

Conditions

Healthy

Study Design

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

Study Groups

telmisartan and ASA/ER-DP (concomitant)

Group Type: EXPERIMENTAL

telmisartan

Intervention Type: DRUG

ASA/ER-DP

Intervention Type: DRUG

ASA/ER-DP alone

Group Type: ACTIVE_COMPARATOR

ASA/ER-DP

Intervention Type: DRUG

telmisartan and ASA/ER-DP (consecutively)

Group Type: EXPERIMENTAL

telmisartan

Intervention Type: DRUG

ASA/ER-DP

Intervention Type: DRUG

telmisartan

Group Type: ACTIVE_COMPARATOR

telmisartan

Intervention Type: DRUG

Interventions

telmisartan

Intervention Type: DRUG

ASA/ER-DP

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy females and males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests

• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease

2. Age ≥21 and Age ≤65 years

3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria

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

2. Surgery of gastrointestinal tract (except appendectomy)

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

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

5. Chronic or relevant acute infections

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

7. 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

8. 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

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

10. Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)

11. Inability to refrain from smoking on trial days

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

13. Drug abuse

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

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

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

17. Inability to comply with dietary regimen of study centre

18. History of hereditary fructose intolerance

19. History of any familial bleeding disorder

20. Veins unsuited for i.v. puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)

21. Inability to comply with the investigators instructions

For female subjects:

22. Pregnancy

23. Positive pregnancy test

24. No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)

25. Inability to maintain this adequate contraception during the whole study period

26. Lactation period

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.458

Identifier Type: -

Identifier Source: org_study_id