Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

Study Overview
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Brief Summary
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To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use

Detailed Description
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Purpose:

Official Title
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Bioequivalence of Telmisartan Administrated in Two Different Ways: Both in Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg Tablet and Amlodipine 5mg Tablet in Concomitant Use in Healthy Male Volunteers. (an Open-label, Randomized, Single-dose, Four-period Replicated Crossover Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Telmisartan/Amlodipin FDC
* Drug: Telmisartan
* Drug: Amlodipin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests Age: =20 and =35 years Body weight: =50 kg and =80 kg Body mass index (BMI): =18.0 and =25.0 kg/m2 Exclusion criteria: Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders Chronic or relevant acute infections Any clinical relevant findings in laboratory test results deviating from normal A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test History of surgery of the gastrointestinal tract (except appendectomy) History of relevant orthostatic hypotension, fainting spells, or blackouts Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin receptor blocker, or to any other dihydropyridine calcium channel blocker compound Intake of drugs with a long half-life (=24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration Participation in another trial with an investigational drug within 1 months or less than 10 times of half-lives of the investigational products before drug administration Smoker (=20 cigarettes/day) Alcohol abuse (60 g or more ethanol/day: e.g., 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 before drug administration) Excessive physical activities (ex. Marathon etc) within 1 week before drug administration Intake of alcohol within 2 days before drug administration Inability to comply with dietary regimen of the study site Inability to refrain from smoking during 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan80mg/Amlodipin5mg FDC<br>single-dose, four-period replicated crossover design | Drug: Telmisartan/Amlodipin FDC<br>* Telmisartan80mg/Amlodipin5mg FDC<br>|
| Experimental: Telmisartan80mgtab + Amlodipin5mg tab<br>single-dose, four-period replicated crossover design | Drug: Telmisartan<br>* Telmisartan 80 mg tablet<br>Drug: Amlodipin<br>* Amlodipin 5mg tablet<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 Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point | Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration | 
| Cmax | maximum measured concentration of Telmisartan in plasma | Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ | area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity | Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration | 
| Tmax | time from dosing to the maximum concentration of Telmisartan in plasma | Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration | 
| λz | terminal rate constant of Telmisartan in plasma | Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration | 
| t1/2 | terminal half-life of Telmisartan in plasma | Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration | 
| MRTpo | mean residence time of Telmisartan in the body after oral administration | Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration |