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The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without the co-administration of lacidipine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacidipine | Experimental |
| |
| Telmisartan | Experimental |
| |
| Lacidipine + Telmisartan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacidipine | Drug |
| ||
| Telmisartan |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant changes in vital signs | up to 12 days after last drug administration | |
| Number of subjects with abnormal changes in laboratory parameters | up to 12 days after last drug administration | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 72 hours after drug administration | |
| Cmin (Minimum measured concentration of the analyte in plasma) | up to 72 hours after drug administration | |
| AUCss (Area under the concentration-time curve of the analyte in plasma at steady state) | 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 | |
| t½ (Terminal half-life of the analyte in plasma) | up to 72 hours after drug administration | |
| MRT (Mean residence time of the analyte in the body) |
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Inclusion Criteria:
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)
Any laboratory value outside the reference range of clinical relevance
Female only:
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| ID | Term |
|---|---|
| C060285 | lacidipine |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
| up to 72 hours after drug administration |
| Number of subjects with adverse events | up to 66 days |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |