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
Condition: Healthy
Intervention: Telmisartan/Amlodipin FDC; Telmisartan; Amlodipin
Intervention description: Telmisartan80mg/Amlodipin5mg FDC; Telmisartan 80 mg tablet; Amlodipin 5mg tablet
Intervention MeSH terms: Telmisartan
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the bioequivalence of telmisartan administrated in two different ways: both in
      telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg
      tablet and amlodipine 5 mg tablets (R) in concomitant use
    

Eligibility criteria:

        Inclusion criteria:

          1. 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

          2. Age: =20 and =35 years

          3. Body weight: =50 kg and =80 kg

          4. Body mass index (BMI): =18.0 and =25.0 kg/m2

        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 or
             neurological disorders

          3. Chronic or relevant acute infections

          4. Any clinical relevant findings in laboratory test results deviating from normal

          5. 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

          6. History of surgery of the gastrointestinal tract (except appendectomy)

          7. History of relevant orthostatic hypotension, fainting spells, or blackouts

          8. 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

          9. 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

         10. 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

         11. 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

         12. Smoker (=20 cigarettes/day)

         13. Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous
             [equivalent to 540 mL] of sake)

         14. Drug abuse

         15. Blood donation (more than 100 mL within 4 weeks before drug administration)

         16. Excessive physical activities (ex. Marathon etc) within 1 week before drug
             administration

         17. Intake of alcohol within 2 days before drug administration

         18. Inability to comply with dietary regimen of the study site

         19. Inability to refrain from smoking during trial days