Status:
COMPLETED
Bioequivalence of Telmisartan Film-coated Tablet Compared With the Conventional Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the conventional 40 mg telmisartan tablet
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, body temperature), 12-lead ECG, clinical laboratory tests
- No findings deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥17.6 and ≤26.4 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with 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 disorders or neurological disorders
- Chronic or relevant acute infections
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for either hepatitis B surface antigen (HBs antigen), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
- History of 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 telmisartan formulation, or to any other angiotensin II receptor blockers (ARBs)
- 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
- Inability to refrain from smoking on trial days
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02263989
Start Date
January 1 2007
Last Update
October 15 2014
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