Telmisartan and Amlodipine Versus Monocomponent Tablets
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Telmisartan/Amlodipine Combination Tablet; Amlodipine Monocomponent
Intervention description: Combination Tablet; Active Comparator
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will be an open-label, randomized, two-treatment, two-period, two-sequence
      crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer
      Ingelheim Pharma GmbH & Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination
      tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy, non-smoking, male and/or post-menopausal/surgically sterile female subjects
             from 18 to 55 years of age.

          2. Females who participate in this study must either:

               1. be post-menopausal for at least 1 year (no menstrual cycle for 12 consecutive
                  months) and deemed post-menopausal by a physician based on screening clinical
                  laboratory tests (Follicle stimulating hormone (FSH) and Luteinising Hormone (LH)

               2. provide proof of surgical sterility.

          3. Body Mass Index (BMI) greater than or equal to 19.0 and less than or equal to 30.0
             kg/m2.

          4. No clinically significant findings in vital signs measurements and systolic blood
             pressure greater than or equal to 110 mmHg at screening.

          5. No clinically significant abnormal laboratory values.

          6. No clinically significant findings in a 12-lead electrocardiogram (ECG) and the time
             between the P and the R waves on the ECG (PR interval) less than or equal to 200 ms at
             screening.

          7. Have no significant diseases.

          8. Be informed of the nature of the study and give written consent prior to receiving any
             study procedure.

          9. Have no clinically significant findings from a physical examination.

        Exclusion criteria:

          1. Known history or presence of any clinically significant medical condition.

          2. Known or suspected carcinoma.

          3. History or presence of cardiovascular dysfunction (e.g. increased angina, myocardial
             infarction, outflow obstruction, congestive heart failure).

          4. History of clinically significant hypotension.

          5. Presence of hepatic dysfunction.

          6. Known history or presence of galactose or fructose intolerance, sucrase-isomaltase
             insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose
             malabsorption syndrome.

          7. History of gastrointestinal tract surgery (appendectomy is permitted).

          8. Presence of clinically significant gastrointestinal disease or history of
             malabsorption within the last year.

          9. Presence of a medical condition requiring regular medication (prescription and/or
             over-the-counter) with systemic absorption.

         10. History of drug or alcohol addiction requiring treatment.

         11. Positive test result for serum hCG consistent with pregnancy (females only), HIV,
             Hepatitis B surface antigen, or Hepatitis C antibody.

         12. Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines,
             cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone, and
             benzodiazepines) or urine cotinine.

         13. Difficulty fasting or consuming standard meals.

         14. Females who are pregnant, lactating, or likely to become pregnant during the study.

         15. Does not tolerate venipuncture.

         16. Use of tobacco or nicotine-containing products within 6 months prior to drug
             administration.

         17. On a special diet within 30 days prior to drug administration (e.g. liquid, protein,
             raw food diet).

         18. Participated in another clinical trial or received an investigational product within
             30 days prior to drug administration.

         19. Donation or loss of whole blood:

               1. Great than or equal to 50 mL and less than or equal to 499 mL within 30 days
                  prior to dosing

               2. greater than or equal to 500 mL within 56 days prior to dosing.

         20. Females who have used hormonal contraceptives within 6 months prior to drug
             administration.

         21. Have had a tattoo or body piercing within 30 days prior to dosing.

         22. Known history or presence of hypersensitivity or idiosyncratic reaction to
             telmisartan, amlodipine, or any other drug substances with similar activity.

         23. Use of any drugs known to:

               1. induce (e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole)

               2. inhibit (e.g. antidepressants (Selective Seratonin Reuptake Inhibitor (SSRI)I),
                  cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil,
                  fluoroquinolones, antihistamines) hepatic drug metabolism within 30 days prior to
                  drug administration.