Pharmacokinetics of Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan in Healthy Subjects

Pharmacokinetics of Single Oral Doses of 40 mg Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan 80 mg Daily, Given Orally Over 6 Days. A Randomised, Placebo Controlled, Double Blind (for Telmisartan), Two Way Cross Over Trial in Healthy Subjects

To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan

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