Status:
COMPLETED
Pharmacokinetics of Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan in Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02187536
Start Date
April 1 2000
Last Update
July 11 2014
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