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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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Telmisartan/Amlodipin FDC (Drug); Telmisartan (Drug); Amlodipin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim


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

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:



Secondary outcome:






Detailed description: Purpose:


Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Male.


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

Locations and Contacts

1235.28.001 Boehringer Ingelheim Investigational Site, Kumamoto, Kumamoto, Japan
Additional Information

Starting date: April 2011
Last updated: February 28, 2014

Page last updated: August 23, 2015

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