Status:
COMPLETED
Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condit...
Eligibility Criteria
Inclusion
- Healthy male volunteers 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
- Age: ≥20 and Age ≤35 years
- Body weight: ≥50 kg
- Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2
- Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation
Exclusion
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
- Chronic or relevant acute infections
- Any clinical relevant findings in laboratory test results deviating from normal
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test
- History of surgery of the gastrointestinal tract (except appendectomy)
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound
- 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
- 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
- Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration
- Smoker (≥20 cigarettes/day)
- Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous \[equivalent to 540 mL\] of sake)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks before drug administration)
- Excessive physical activities (within 1 week before drug administration)
- Intake of alcohol within 2 days before drug administration
- Inability to comply with dietary regimen of the study centre
- Inability to refrain from smoking during trial days
- Subjects judged to be inappropriate by the investigator or a sub-investigator
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02261064
Start Date
December 1 2008
Last Update
October 10 2014
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