Healthy
Conditions
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
Interventions
DRUGLacidipine
DRUGTelmisartan
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed