Clinical trial NCT02187536: Pharmacokinetics of Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan in Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax)
timeFrame: Pre-dose, up to day 32 after start of treatment
Secondary outcomes:
measure: Time to Cmax after a single extravascular dose (tmax)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Elimination half-life in plasma (t1/2)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Total clearance from plasma (CLtot/f)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Mean time of residence in the body (MRTtot)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Apparent volume of distribution during the terminal phase (Vz/f)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Area under the plasma concentration-time curve of telmisartan at steady state (AUCss)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Maximum concentration of telmisartan in plasma at steady state (Cmax,ss)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Number of patients with clinically relevant findings in laboratory values
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)
timeFrame: Pre-dose, up to day 32 after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to day 32 after start of treatment
measure: Number of patients with clinically relevant findings in ECG
timeFrame: Pre-dose, up to day 32 after start of treatment
Other outcomes:
Locations:
Study officials:
References: