Bioequivalence of Telmisartan / HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers

Study Overview
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Brief Summary
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To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ vs. its monocomponents

Official Title
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Bioequivalence of 40 mg Telmisartan / 12.5 mg HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Hydrochlorthiazide (HCTZ)
* Drug: Telmisartan/HCTZ fixed dose


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, the physical examination (physical findings and measurements of height and body weight), vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests No finding of clinical relevance No evidence of a clinically relevant concomitant disease Age ≥20 years and Age ≤35 years BMI ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2 (Body Mass Index) Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)(MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation. Exclusion Criteria: Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of gastrointestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of relevant orthostatic hypotension, fainting spells or blackouts. Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Positive result for Hepatitis B virus surface antigen (HBsAg), anti Hepatitis C virus (HCV) anti bodies, syphilitic test or Human immunodeficiency virus (HIV) test 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 10 days prior to administration or during the trial. Participation in another trial with an investigational drug within four months prior to administration or during the trial Smoker (more than 20 cigarettes/day) Inability to refrain from smoking during hospitalisation Alcohol abuse (more than 60 g/day as ethanol ex.) three middle sized bottles of beer / three gous (equivalent to 540 mL) of sake) Drug abuse Blood donation (more than 100 mL within four weeks prior to administration or during the trial) Excessive physical activities (within one week prior to administration or during the trial) Any laboratory value outside the reference range that is of clinical relevance Inability to comply with dietary regimen of study centre Any other volunteers whom, the principal investigator or sub investigator would not allow to participate this study

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/HCTZ fixed dose<br> | Drug: Telmisartan/HCTZ fixed dose<br> <br> |
| Active Comparator: Telmisartan and HCTZ monocomponents<br> | Drug: Telmisartan<br> <br> Drug: Hydrochlorthiazide (HCTZ)<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 the 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 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 participants with abnormal findings in physical examination |  | Up to 9 days after last drug administration | 
| Number of participants with clinically significant findings in vital signs |  | Up to 9 days after last drug administration | 
| Number of participants with clinically significant findings in 12-lead ECG (electrocardiogram) |  | Up to 9 days after last drug administration | 
| Number of participants with clinically significant findings in laboratory parameters |  | Up to 9 days after last drug administration | 
| Number of participants with adverse events |  | Up to 9 days after last drug administration |