Status:
COMPLETED
Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Study to investigate the relative bioavailability of fixed-dose combination tablet vs. mono-components of telmisartan and amlodipine
Eligibility Criteria
Inclusion
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead ECG, clinical laboratory tests, no finding of clinical relevance, no evidence of a clinically relevant concomitant disease
- Age ≥20 and Age ≤35 years
- Body weight ≥50 kg
- BMI ≥17.6 and BMI ≤26.4 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice
Exclusion
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for hepatitis B antigen, anti hepatitis C virus anti bodies, syphilitic test or HIV test
- Surgery of gastrointestinal tract (except appendectomy)
- History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varies by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varies by ≥10 mmHg from mean supine DBP), fainting spells or blackouts
- History of hepatic dysfunction (e.g. biliary cirrhosis, cholestasis)
- History of serious renal dysfunction
- History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
- History of cerebrovascular disorder
- History of hyperkalemia
- Known hypersensitivity to any component of the formulation, or to any other angiotensin II receptor blockers, angiotensin converting enzyme or dihydropyridine
- Intake of drugs with a long half-life (≥24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days prior to administration or during the trial
- Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug prior to administration
- Smoker (≥20 cigarettes/day)
- Alcohol abuse (60 g or more ethanol/day: ex. 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 prior to administration or during the trial)
- Excessive physical activities (within 1 week prior to administration or during the trial)
- Intake of alcohol within 2 days prior to administration
- Inability to comply with dietary regimen of study centre
- Intake of any drugs/supplements with ingredient of hypericum perforatum or citrus fruits (e.g. grapefruits, Sevilla orange) within 5 days prior to administration
- Inability to refrain from smoking on trial days
- Any other volunteers whom, the principal investigator or sub investigator would not allow to participate in this study
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02259803
Start Date
October 1 2007
Last Update
October 9 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.