Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Tolerability and Pharmacokinetics of 80 mg Telmisartan and 6 mg Lacidipine Alone and in Combination After 7 Days Treatment. An Open Randomised Three-way Cross-over Trial in Female and Male Healthy Subjects

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female 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) Any laboratory value outside the reference range of clinical relevance Female only: no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization) Pregnancy or breast feeding period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacidipine<br> | Drug: Lacidipine<br> <br> |
| Experimental: Telmisartan<br> | Drug: Telmisartan<br> <br> |
| Experimental: Lacidipine + Telmisartan<br> | Drug: Lacidipine<br> <br> Drug: Telmisartan<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) |  | up to 72 hours after drug administration | 
| Number of subjects with adverse events |  | up to 66 days |