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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ASA/ER-DP; Drug: telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262793

502.458

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

telmisartan and ASA/ER-DP (concomitant)

Experimental group

Treatment:

Drug: telmisartan

Drug: ASA/ER-DP

ASA/ER-DP alone

Active Comparator group

Treatment:

Drug: ASA/ER-DP

telmisartan and ASA/ER-DP (consecutively)

Experimental group

Treatment:

Drug: telmisartan

Drug: ASA/ER-DP

telmisartan

Active Comparator group

Treatment:

Drug: telmisartan