Status:
COMPLETED
Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
Study to demonstrate the bioequivalence of the telmisartan 80 mg film-coated tablet vs. two tablets of the telmisartan 40 mg conventional tablet
Eligibility Criteria
Inclusion
- Healthy Japanese 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
- 1 No findings deviating from normal and of clinical relevance
- 2 No evidence of a clinically relevant concomitant disease
- Age ≥20 and ≤35 years
- Body weight≥50kg
- Body Mass Index ≥18.0 and ≤25.0 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- 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
- History of relevant allergy/hypersensitivity (including allergy to a drug or its excipients)
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for either hepatitis B antigen, anti hepatitis C virus 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
- 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 before administration of the investigational product
- Use of any drugs within 10 days before administration of the investigational product or during the trial
- Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial
- Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
- Alcohol abuse
- Drug abuse
- Blood donation (100 mL or more) within four weeks before administration of the investigational product
- Excessive physical activities within one week before administration of the investigational product 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
- Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02261129
Start Date
September 1 2008
Last Update
October 10 2014
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