Telmisartan, Amlodipine and Combination in Healthy Subjects
Condition: Healthy
Intervention: amlodipine/telmisartan/combination
Intervention description: patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose
      combination after single dose in healthy Chinese subjects.

      To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine,
      following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and
      in combination, in healthy Chinese subjects.

      To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy
      Chinese subjects.
    

Eligibility criteria:

        Inclusion criteria

          1. Healthy males and females

          2. Aged between 18 and 45 years

          3. Body weight more than 50Kg , and Body Mass Index (BMI ) between 19 and 24 kg/m2

        Exclusion criteria

          1. Any finding of the medical examination deviating from normal and of clinical relevance

          2. Any evidence of a clinically relevant concomitant disease

          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          4. Surgery of the gastrointestinal tract (except appendectomy)

          5. Diseases of the central nervous system or psychiatric disorders or neurological
             disorders

          6. History of relevant orthostatic hypotension, fainting spells or blackouts.

          7. Chronic or relevant acute infections

          8. History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients)

          9. 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

         10. Use of drugs which might reasonably influence the results of the trial

         11. Participation in another trial with an investigational drug within two months prior to
             administration or during the trial

         12. Smoker

         13. Inability to refrain from smoking during 24 hours prior to dosing and during the trial

         14. Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing
             and during the trial

         15. Drug abuse

         16. Blood donation (more than 100 mL within four weeks prior to administration or during
             the trial)

         17. Excessive physical activities (within one week prior to administration or during the
             trial)

         18. Any laboratory value outside the reference range that is of clinical relevance

         19. Inability to comply with dietary regimen of trial site

         20. A history of additional risk factors for torsade de pointes

         21. Any history of relevant low blood pressure

         22. Supine blood pressure at screening of systolic <110 mm Hg and diastolic < 60 mm Hg

         23. History of urticaria

         24. History of angioneurotic edema 25 Pregnancy / positive pregnancy test, or planning to
             become pregnant during the study or within 1 month of study completion

        26. No adequate contraception during the study and until 1 month of study completion 27.
        Lactation period