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Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Telmisartan low
Drug: amlodipine
Drug: Telmisartan high

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days

Enrollment

24 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers according to the following criteria:

  1. No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
  2. Age ≥20 and Age ≤35 years
  3. Body weight ≥50 kg
  4. Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
  5. Signed and dated written informed consent before admission to the trial

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 either hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
  6. History of surgery of gastrointestinal tract (except appendectomy)
  7. History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varied by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varied 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 Receptor Blocker (ARB), 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 before 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 before 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 before 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 before administration or during the trial)
  21. Excessive physical activities (within 1 week before administration or during the trial)
  22. Intake of alcohol within 2 days before administration
  23. Inability to comply with dietary regimen of trial centre
  24. Intake of any drugs/supplements with ingredient of hypericum perforatum (citrus fruits, Sevilla orange) within 5 days prior to administration
  25. Inability to refrain from smoking on trial days

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Telmisartan low + amlodipine
Experimental group
Treatment:
Drug: amlodipine
Drug: Telmisartan low
Telmisartan high + amlodipine
Experimental group
Treatment:
Drug: Telmisartan high
Drug: amlodipine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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