Pharmacokinetics of Telmisartan Alone and in Combination With Amlodipine in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02259816

1235.2

Details and patient eligibility

About

Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in combination with repeated doses of 10 mg amlodipine

Enrollment: 38 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

2. Age ≥18 and Age ≤50 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 and the local legislation

Exclusion criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

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

4. Surgery of the gastrointestinal tract (except appendectomy)

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

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

7. Chronic or relevant acute infections

8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

9. 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

10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/corrected QT interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial

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

12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

13. Inability to refrain from smoking on trial days

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

15. Drug abuse

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

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

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

19. Inability to comply with dietary regimen of trial site

20. Any history of relevant low blood pressure

21. Supine blood pressure at screening of systolic <110 mm Hg and/or diastolic <60 mm Hg

22. History of urticaria

    For female subjects:

23. Pregnancy or planning to become pregnant within 2 months of study completion

24. Positive pregnancy test

25. No adequate contraception e.g. sterilisation, intrauterine device, have not been using a barrier method of contraception for at least 3 months prior to participation in the study

26. Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial

27. Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception

28. Partner is unwilling to use condoms

29. Lactation period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Telmisartan

Active Comparator group

Treatment:

Drug: Telmisartan

Telmisartan and amlodipine

Experimental group

Treatment:

Drug: Amlodipine

Drug: Telmisartan