Pharmacokinetics of Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan in Healthy Subjects
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Telmisartan (Drug); Simvastatin (Drug); Telmisartan placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant
administration of telmisartan
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax)
Secondary outcome: Time to Cmax after a single extravascular dose (tmax)Elimination half-life in plasma (t1/2) Total clearance from plasma (CLtot/f) Mean time of residence in the body (MRTtot) Apparent volume of distribution during the terminal phase (Vz/f) Area under the plasma concentration-time curve of telmisartan at steady state (AUCss) Maximum concentration of telmisartan in plasma at steady state (Cmax,ss) Number of patients with clinically relevant findings in laboratory values Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate) Number of patients with adverse events Number of patients with clinically relevant findings in ECG
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 2000
Last updated: July 9, 2014
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