Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers

Study Overview
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Brief Summary
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Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition in healthy Japanese male volunteers.

Official Title
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Influence of Food on the Bioavailability of Telmisartan 40 mg/Amlodipine 5 mg Fixed-dose Combination and of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination in Healthy Japanese Male Volunteers (a Phase I, Open-label, Randomised, Single-dose, Two-way Crossover Trial)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Telmisartan/Amlodipine low dose
* Drug: Telmisartan/Amlodipine high dose
* Other: Japanese meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers 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 Age ≤35 years Body weight: ≥50 kg Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2 Signed and dated written informed consent prior to admission to the trial in accordance with the 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 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 syphilitic 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 II receptor blockers, or to any other dihydropyridine 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 4 months or 6 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 (within 1 week before drug administration) Intake of alcohol within 2 days before drug administration Inability to comply with dietary regimen of the study centre Inability to refrain from smoking during trial days Subjects judged to be inappropriate by the investigator or a sub-investigator

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/Amlodipine low dose, fed<br>Telmisartan low dose/Amlodipine fixed-dose combination | Drug: Telmisartan/Amlodipine low dose<br> <br> Other: Japanese meal<br> <br> |
| Active Comparator: Telmisartan/Amlodipine low dose, fasted<br>Telmisartan low dose/Amlodipine fixed-dose combination | Drug: Telmisartan/Amlodipine low dose<br> <br> |
| Experimental: Telmisartan/Amlodipine high dose, fed<br>Telmisartan high dose/Amlodipine fixed-dose combination | Drug: Telmisartan/Amlodipine high dose<br> <br> Other: Japanese meal<br> <br> |
| Active Comparator: Telmisartan/Amlodipine high dose, fasted<br>Telmisartan high dose/Amlodipine fixed-dose combination | Drug: Telmisartan/Amlodipine high dose<br> <br> |

What is the study measuring?
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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 the time of the last quantifiable data point (AUC0-tz) |  | up to 144 hours after drug administration | 
| Maximum measured concentration of the analyte in plasma (Cmax) |  | up to 144 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 144 hours after drug administration | 
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) |  | up to 144 hours after drug administration | 
| Terminal rate constant of the analyte in plasma (λz) |  | up to 144 hours after drug administration | 
| Terminal half-life of the analyte in plasma (t1/2) |  | up to 144 hours after drug administration | 
| Mean residence time of the analyte in the body after po administration (MRTpo) |  | up to 144 hours after drug administration | 
| Number of subjects with adverse events |  | up to 56 days |