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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01344629
First received: April 26, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Telmisartan/Amlodipin FDC
Drug: Telmisartan
Drug: Amlodipin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence of Telmisartan Administrated in Two Different Ways: Both in Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg Tablet and Amlodipine 5mg Tablet in Concomitant Use in Healthy Male Volunteers. (an Open-label, Randomized, Single-dose, Four-period Replicated Crossover Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUC0-tz [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point

  • Cmax [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration ] [ Designated as safety issue: No ]
    maximum measured concentration of Telmisartan in plasma


Secondary Outcome Measures:
  • AUC0-∞ [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration ] [ Designated as safety issue: No ]
    area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity

  • Tmax [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration ] [ Designated as safety issue: No ]
    time from dosing to the maximum concentration of Telmisartan in plasma

  • λz [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration ] [ Designated as safety issue: No ]
    terminal rate constant of Telmisartan in plasma

  • t1/2 [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration ] [ Designated as safety issue: No ]
    terminal half-life of Telmisartan in plasma

  • MRTpo [ Time Frame: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration ] [ Designated as safety issue: No ]
    mean residence time of Telmisartan in the body after oral administration


Enrollment: 64
Study Start Date: April 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telmisartan80mg/Amlodipin5mg FDC
single-dose, four-period replicated crossover design
Drug: Telmisartan/Amlodipin FDC
Telmisartan80mg/Amlodipin5mg FDC
Experimental: Telmisartan80mgtab + Amlodipin5mg tab
single-dose, four-period replicated crossover design
Drug: Telmisartan
Telmisartan 80 mg tablet
Drug: Amlodipin
Amlodipin 5mg tablet

Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01344629

Locations
Japan
1235.28.001 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01344629     History of Changes
Other Study ID Numbers: 1235.28
Study First Received: April 26, 2011
Results First Received: July 10, 2012
Last Updated: February 28, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 16, 2014