Bioequivalence of Telmisartan Film-coated Tablet Compared With the Conventional Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers

Study Overview
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Brief Summary
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Study to investigate the bioequivalence of the 40 mg telmisartan film-coated tablet vs. the conventional 40 mg telmisartan tablet

Official Title
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Bioequivalence of the 40 mg Telmisartan Film-coated Tablet Compared With the Conventional 40 mg Telmisartan Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Telmisartan film coated tablet
* Drug: Telmisartan conventional tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan film coated tablet<br> | Drug: Telmisartan film coated tablet<br> <br> |
| Active Comparator: Telmisartan conventional tablet<br> | Drug: Telmisartan conventional tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable data point) |  | up to 72 hours after drug administration | 
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 72 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 72 hours after drug administration | 
| tmax (time from dosing to the maximum measured concentration of the analyte in plasma) |  | up to 72 hours after drug administration | 
| λz (terminal rate constant of the analyte in plasma) |  | up to 72 hours after drug administration | 
| t1/2 (terminal half-life of the analyte in plasma) |  | up to 72 hours after drug administration | 
| MRTpo (mean residence time of the analyte in the body after po administration) |  | up to 72 hours after drug administration | 
| Number of subjects with adverse events |  | up to 72 hours after last administration | 
| Number of subjects with clinically significant findings in vital signs | blood pressure, pulse rate, body temperature | up to 72 hours after last administration | 
| Number of subjects with clinically significant findings in 12-lead electrocardiogram |  | up to 72 hours after last administration | 
| Number of subjects with clinically significant findings in laboratory tests |  | up to 72 hours after last administration | 
| Number of subjects with clinically significant findings in physical examination |  | up to 72 hours after last administration |