Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan/amlodipine fixed-dose combination tablet; Drug: Telmisartan; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02259790

1235.17

Details and patient eligibility

About

Study to investigate the relative bioavailability of fixed-dose combination tablet vs.

mono-components of telmisartan and amlodipine

Enrollment: 30 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests, no finding of clinical relevance, no evidence of a clinically relevant concomitant disease

2. Age ≥20 and Age ≤35 years

3. Body weight ≥50 kg

4. BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)

5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice

Exclusion criteria

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. Chronic or relevant acute infections
4. Any clinical relevant findings of the laboratory test deviating from normal
5. Positive result for hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or HIV test
6. Surgery of gastrointestinal tract (except appendectomy)
7. History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varies by ≥10 mmHg from mean supine DBP), fainting spells or blackouts
8. History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)
9. History of serious renal dysfunction
10. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
11. History of cerebrovascular disorder
12. History of hyperkalemia
13. Known hypersensitivity to any component of the formulation, or to any other angiotensin II receptor antagonists, angiotensin converting enzyme or dihydropyridine
14. 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
15. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial
16. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
17. Smoker (≥20 cigarettes/day)
18. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
19. Drug abuse
20. Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
21. Excessive physical activities (within 1 week prior to administration or during the trial)
22. Intake of alcohol within 2 days prior to administration
23. Inability to comply with dietary regimen of study centre
24. Intake of any drugs/supplements with ingredient of hypericum perforatum or citrus fruits (e.g. grapefruits, Sevilla orange) within 5 days prior to administration
25. Inability to refrain from smoking on trial days
26. Any other volunteers whom, the principal investigator or sub investigator would not allow to participate in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Telmisartan/amlodipine fixed-dose combination

Experimental group

Treatment:

Drug: Telmisartan/amlodipine fixed-dose combination tablet

Telmisartan tablet and amlodipine tablet

Active Comparator group

Treatment:

Drug: Telmisartan

Drug: Amlodipine