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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

Page last updated: August 23, 2015

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