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Telmisartan and Amlodipine Versus Monocomponent Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278797
Recruitment Status : Completed
First Posted : January 19, 2011
Results First Posted : March 16, 2012
Last Update Posted : March 28, 2014
Information provided by:
Boehringer Ingelheim

Brief 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).

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan/Amlodipine Combination Tablet Drug: Amlodipine Monocomponent Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Basic Science
Official Title: A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions
Study Start Date : January 2011
Actual Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Telmisartan/Amlodipine Fixed Dose
Telmisartan/Amlodipine medium fixed dose combination tablet once daily.
Drug: Telmisartan/Amlodipine Combination Tablet
Combination Tablet

Active Comparator: Amlodipine Monocomponent
Amlodipine Monocomponent 10mg tablet once daily
Drug: Amlodipine Monocomponent
Active Comparator

Primary Outcome Measures :
  1. Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72) [ Time Frame: Day 1, Day 22 ]
    Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method

  2. Maximum Observed Plasma Concentration (Cmax) of Amlodipine [ Time Frame: Day 1, Day 22 ]

Secondary Outcome Measures :
  1. Time of Maximum Concentration of Amlodipine (TMAX) [ Time Frame: Day 1, Day 22 ]
    Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278797

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Canada, Ontario
1235.41.0001 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT01278797    
Other Study ID Numbers: 1235.41
First Posted: January 19, 2011    Key Record Dates
Results First Posted: March 16, 2012
Last Update Posted: March 28, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Telmisartan amlodipine combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists