CompletedPhase 1ACTRN12611000315910

To determine whether a pharmacokinetic drug-drug interaction occurs between atorvastatin and elinogrel.

An open-label, single sequence study to assess the potential pharmacokinetic drug-drug interaction of elinogrel and atorvastatin at steady-state in healthy adult subjects

Sponsor

Novartis Pharmaceutical Pty Limited

Enrollment

28 participants

Start Date

Apr 7, 2011

Study Type

Interventional

Conditions

chronic coronary heart disease (CHD)

Summary

Elinogrel is under the development for the treatment of patients with chronic coronary heart disease and acute coronary syndrome. Patient’s treated for these conditions are likely to be on a statin therapy such as atorvastatin in addition to other anticoagulants such as Elinogrel. Hence the need to investigate the potential drug interaction between Elinogrel and atorvastatin

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study checks whether taking atorvastatin (a common cholesterol-lowering drug) together with elinogrel (a blood-thinning medication) causes any drug interaction that could affect how either medication works in the body. Healthy adults aged 18-45 will take both drugs so researchers can measure blood levels and safety.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

All participants will undergo a single sequence 3 treatment period as outlined below. Treatment periods are without overlap and with at least 5 days seperating each treatment period. There will be

All participants will undergo a single sequence 3 treatment period as outlined below. Treatment periods are without overlap and with at least 5 days seperating each treatment period. There will be three treatment phases. Treatment 1 (Period 1 – 5 days) Elingrel at a dose of 150 mg twice a day for 5 days. Treatment 2 (Period 2 – 10 days) atorvastatin at a dose of 40 mg once a day for the first 5 days followed by Elinogrel at a dose of 150 mg twice a day and atorvastatin at a dose of 40 mg once a day for the last 5 days. There will be no evening dose on the last day. Treatment 3 (Period 3 – 10 days) atorvastatin at a dose of 80 mg once a day for the first 5 days followed by Elinogrel at a dose of 150 mg twice a day and atorvastatin at a dose of 80 mg once a day for the last 5 days. There will be no evening dose on the last day.

Locations(1)

VIC, Australia

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ACTRN12611000315910