Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

Purpose:

Inclusion criteria

• Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
• Age: =20 and =35 years
• Body weight: =50 kg and =80 kg
• Body mass index (BMI): =18.0 and =25.0 kg/m2

Exclusion criteria

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
• Chronic or relevant acute infections
• Any clinical relevant findings in laboratory test results deviating from normal
• A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test
• History of surgery of the gastrointestinal tract (except appendectomy)
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin receptor blocker, or to any other dihydropyridine calcium channel blocker compound
• Intake of drugs with a long half-life (=24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration
• Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration
• Participation in another trial with an investigational drug within 1 months or less than 10 times of half-lives of the investigational products before drug administration
• Smoker (=20 cigarettes/day)
• Alcohol abuse (60 g or more ethanol/day: e.g., 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 drug administration)
• Excessive physical activities (ex. Marathon etc) within 1 week before drug administration
• Intake of alcohol within 2 days before drug administration
• Inability to comply with dietary regimen of the study site
• Inability to refrain from smoking during trial days