Bioequivalence of Telmisartan Film-coated Tablet Compared With Two Tablets of the Conventional Telmisartan Tablet in Healthy Male Volunteers

Study Overview
=================
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

Official Title
-----------------
Bioequivalence of the 80 mg Telmisartan Film-coated Tablet Compared With Two Tablets of 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
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Telmisartan film-coated tablet
* Drug: Telmisartan uncoated tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 1.1 No findings deviating from normal and of clinical relevance 1.2 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 Criteria: 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

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>one tablet of telmisartan | Drug: Telmisartan film-coated tablet<br> <br> |
| Active Comparator: Telmisartan, conventional tablet<br>Two tablets of telmisartan | Drug: Telmisartan uncoated tablet<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) |  | up to 72 hours after drug administration | 
| Time from dosing to the maximum measured concentration of the analyte in plasma (tmax) |  | up to 72 hours after drug administration | 
| Terminal rate constant of the analyte in plasma (λz) |  | up to 72 hours after drug administration | 
| Terminal half-life of the analyte in plasma (t1/2) |  | up to 72 hours after drug administration | 
| mean residence time of the analyte in the body after po administration (MRTpo) |  | up to 72 hours after drug administration | 
| Number of subjects with adverse events |  | up to 72 hours after last drug administration |