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
Summary
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: AUC0-tzCmax
Secondary outcome: AUC0-∞Tmax λz t1/2 MRTpo
Detailed description:
Purpose:
Eligibility
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Male.
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
Locations and Contacts
1235.28.001 Boehringer Ingelheim Investigational Site, Kumamoto, Kumamoto, Japan
Additional Information
Starting date: April 2011
Last updated: February 28, 2014
|