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

NCT02187536 | Completed Phase 1

• 1 other identifier: 502.341
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)

  Pre-dose, up to day 32 after start of treatment

• Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax)

  Pre-dose, up to day 32 after start of treatment

Secondary Outcomes (11)

• Time to Cmax after a single extravascular dose (tmax)

  Pre-dose, up to day 32 after start of treatment

• Elimination half-life in plasma (t1/2)

  Pre-dose, up to day 32 after start of treatment

• Total clearance from plasma (CLtot/f)

  Pre-dose, up to day 32 after start of treatment

• Mean time of residence in the body (MRTtot)

  Pre-dose, up to day 32 after start of treatment

• Apparent volume of distribution during the terminal phase (Vz/f)

  Pre-dose, up to day 32 after start of treatment

Study Arms (2)

Telmisartan combined with Simvastatin

EXPERIMENTAL

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

Drug: Telmisartan; Drug: Simvastatin

Simvastatin and telmisartan placebo

ACTIVE COMPARATOR

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

Drug: Simvastatin; Drug: Telmisartan placebo

Interventions

Telmisartan DRUG

Telmisartan combined with Simvastatin

Simvastatin DRUG

Simvastatin and telmisartan placebo; Telmisartan combined with Simvastatin

Telmisartan placebo DRUG

Simvastatin and telmisartan placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 %

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; Simvastatin

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: April 1, 2000
• Primary Completion: May 1, 2000
• Last Updated: July 11, 2014

Record last verified: 2014-07