Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers

Inclusion criteria

• Healthy Japanese males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (Blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests

• 1.1 No findings deviating from normal and of clinical relevance
• 1.2 No evidence of a clinically relevant concomitant disease
• Age ≥20 and ≤35 years
• Body weight≥50kg
• Body Mass Index ≥18.0 and ≤25.0 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• 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
• History of relevant allergy/hypersensitivity (including allergy to a drug or its excipients)
• Any clinical relevant findings of the laboratory test deviating from normal
• Positive result for either hepatitis B antigen, anti hepatitis C virus 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) 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 telmisartan formulation, or to any other angiotensin II receptor blockers
• 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 of the investigational product
• Use of any drugs within 10 days before administration of the investigational product or during the trial
• Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial
• Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
• Alcohol abuse
• Drug abuse
• Blood donation (100 mL or more) within four weeks before administration of the investigational product
• Excessive physical activities within one week before administration of the investigational product or during the trial
• Intake of alcohol within 2 days prior to administration
• Inability to comply with dietary regimen of study centre
• Inability to refrain from smoking on trial days
• Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation