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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Telmisartan placebo; Drug: Telmisartan; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187536

502.341

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Telmisartan combined with Simvastatin

Experimental group

Description:

Telmisartan once daily (day 1 to day 6) and Simvastatin given once (day 6)

Treatment:

Drug: Telmisartan

Drug: Simvastatin

Simvastatin and telmisartan placebo

Active Comparator group

Description:

Telmisartan placebo once daily (day 1 to day 6) and Simvastatin given once (day 6)

Treatment:

Drug: Simvastatin

Drug: Telmisartan placebo