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

Inclusion criteria

• 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

• Age ≥20 and Age ≤35 years
• Body weight ≥50 kg
• BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice

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 hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or HIV test
• Surgery of gastrointestinal tract (except appendectomy)
• 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
• 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 II receptor antagonists, 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 prior to 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 prior to administration or during the trial
• Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to 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 prior to administration or during the trial)
• Excessive physical activities (within 1 week prior to administration or during the trial)
• Intake of alcohol within 2 days prior to administration
• Inability to comply with dietary regimen of study centre
• Intake of any drugs/supplements with ingredient of hypericum perforatum or citrus fruits (e.g. grapefruits, Sevilla orange) within 5 days prior to administration
• Inability to refrain from smoking on trial days
• Any other volunteers whom, the principal investigator or sub investigator would not allow to participate in this study