Telmisartan and Amlodipine Versus Monocomponent Tablets

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01278797
First received: January 17, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Hypertension
Drug: Telmisartan/Amlodipine Combination Tablet
Drug: Amlodipine Monocomponent
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72) [ Time Frame: Day 1, Day 22 ] [ Designated as safety issue: No ]
    Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method

  • Maximum Observed Plasma Concentration (Cmax) of Amlodipine [ Time Frame: Day 1, Day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of Maximum Concentration of Amlodipine (TMAX) [ Time Frame: Day 1, Day 22 ] [ Designated as safety issue: No ]
    Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period


Enrollment: 28
Study Start Date: January 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278797

Locations
Canada, Ontario
1235.41.0001 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01278797     History of Changes
Other Study ID Numbers: 1235.41
Study First Received: January 17, 2011
Results First Received: February 13, 2012
Last Updated: February 28, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014