Tolerability and Pharmacokinetics of Telmisartan in Combination With Lacidipine in Healthy Male Subjects

Study Overview
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Brief Summary
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The trial objectives were to investigate the tolerability and pharmacokinetics of 80 mg telmisartan and 2, 4 or 6 mg lacidipine administered concurrently.

Official Title
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Tolerability and Pharmacokinetics of 80 mg Telmisartan in Combination With 2, 4, or 6 mg Lacidipine. An Open, Single Rising Dose Group Comparison Trial - Placebo Randomised Double Blind in Each Dose Group - in Male Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Lacidipine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male caucasian subjects as determined by results of screening Written informed consent in accordance with Good Clinical Practice and local legislation given Age >= 18 and <= 50 years Broca >= -20% and <= + 20% Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance 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 neurologic disorders History of 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 Intake of drugs with a long half-life (> 24 hours) (<= 1 month prior to administration or during the trial) Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial) Participation in another trial with an investigational drug (<= 2 months prior to administration or during the trial) Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) Inability to refrain from smoking on study days Alcohol abuse (> 60g/day) Drug abuse Blood donation > 100 ml (<= 4 weeks prior to administration or during the trial) Excessive physical activities (<= 10 days prior to administration or during the trial) Any laboratory value outside the reference range of clinical relevance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan + Lacidipine - low dose<br> | Drug: Telmisartan<br> <br> Drug: Lacidipine<br> <br> |
| Experimental: Telmisartan + Lacidipine - medium dose<br> | Drug: Telmisartan<br> <br> Drug: Lacidipine<br> <br> |
| Experimental: Telmisartan + Lacidipine - high dose<br> | Drug: Telmisartan<br> <br> Drug: Lacidipine<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum measured concentration of the analyte in plasma) |  | up to 72 hours after drug administration | 
| Number of subjects with adverse events |  | up to 72 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (Area under the concentration-time curve of the analyte in plasma) |  | 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 | 
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) |  | up to 72 hours after drug administration | 
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) |  | up to 72 hours after drug administration | 
| MRT (Mean residence time of the analyte in the body) |  | up to 72 hours after drug administration | 
| t½ (Terminal half-life of the analyte in plasma) |  | up to 72 hours after drug administration | 
| Number of subjects with abnormal changes in laboratory parameters |  | up to 72 hours after drug administration | 
| Number of subjects with clinically significant changes in vital signs |  | up to 72 hours after drug administration |