Healthy
Conditions
Brief summary
To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects as determined by results of screening * Signed written informed consent in accordance with good clinical practice (GCP) and local legislation * Age ≥ 18 and ≤ 55 years * Broca ≥ -20 % and ≤ +20 %
Exclusion criteria
* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastro-intestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg * History of orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infection * 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 (30 days prior to administration or during the trial) * Smoker * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (≤ 1 month prior to administration or during the trial) * Excessive physical activities (≤ 5 days prior to administration or during the trial) * Any laboratory value outside the reference range of clinical relevance * Hypersensitivity to telmisartan and/or simvastatin and/or related classes of drugs For female subjects: * Pregnancy * Positive pregnancy test * No adequate contraception (e.g. sterilization, intrauterine device (IUD), oral contraceptives) * Inability to maintain this adequate contraception during the whole study period * Lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC) | Pre-dose, up to day 32 after start of treatment |
| Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax) | Pre-dose, up to day 32 after start of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Elimination half-life in plasma (t1/2) | Pre-dose, up to day 32 after start of treatment |
| Total clearance from plasma (CLtot/f) | Pre-dose, up to day 32 after start of treatment |
| Mean time of residence in the body (MRTtot) | Pre-dose, up to day 32 after start of treatment |
| Apparent volume of distribution during the terminal phase (Vz/f) | Pre-dose, up to day 32 after start of treatment |
| Number of patients with clinically relevant findings in ECG | Pre-dose, up to day 32 after start of treatment |
| Maximum concentration of telmisartan in plasma at steady state (Cmax,ss) | Pre-dose, up to day 32 after start of treatment |
| Number of patients with clinically relevant findings in laboratory values | Pre-dose, up to day 32 after start of treatment |
| Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate) | Pre-dose, up to day 32 after start of treatment |
| Number of patients with adverse events | Up to day 32 after start of treatment |
| Area under the plasma concentration-time curve of telmisartan at steady state (AUCss) | Pre-dose, up to day 32 after start of treatment |
| Time to Cmax after a single extravascular dose (tmax) | Pre-dose, up to day 32 after start of treatment |
Outcome results
None listed