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

Inclusion criteria

Healthy male volunteers according to the following criteria:

• 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
• Age ≥20 and Age ≤35 years
• Body weight ≥50 kg
• Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
• Signed and dated written informed consent before admission to the trial

Exclusion criteria

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Chronic or relevant acute infections
• Any clinical relevant findings of the laboratory test deviating from normal
• Positive result for either hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
• History of surgery of gastrointestinal tract (except appendectomy)
• 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
• History of hepatic dysfunction (e.g., biliary cirrhosis, cholestasis)
• History of serious renal dysfunction
• History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
• History of cerebrovascular disorder
• History of hyperkalemia
• Known hypersensitivity to any component of the formulation, or to any other Angiotensin Receptor Blocker (ARB), angiotensin converting enzyme or dihydropyridine
• 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
• 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
• Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug before administration
• Smoker (≥20 cigarettes/day)
• Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks before administration or during the trial)
• Excessive physical activities (within 1 week before administration or during the trial)
• Intake of alcohol within 2 days before administration
• Inability to comply with dietary regimen of trial centre
• Intake of any drugs/supplements with ingredient of hypericum perforatum (citrus fruits, Sevilla orange) within 5 days prior to administration
• Inability to refrain from smoking on trial days