NCT02817932

A Study of Pharmacokinetics and Safety of Ranolazine PR in Healthy Korean and Caucasian Male Subjects

A Single-center, Open-label, Ascending Single- and Multiple-oral Dose Study to Evaluate the Pharmacokinetics and Safety of Ranolazine PR in Healthy Korean and Caucasian Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: A.Menarini Asia-Pacific Holdings Pte Ltd · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is: To assess the pharmacokinetic profile and safety of ranolazine PR in healthy Korean and Caucasian volunteers after oral administration of Ranolazine at the doses of 375, 500, 750mg after single and repeated oral administrations.

Detailed description

Ranolazine is an antianginal drug that exerts its effects by inhibition of the late sodium current in cardiac cells. This action reduces intracellular sodium accumulation and consequently decreases intracellular calcium overload which is expected to reduce myocardial stiffness, oxygen consumption and ATP utilization and improve blood flow to the microvasculature.These effects of ranolazine do not depend upon reductions in heart rate or blood pressure or vasodilation. Ranolazine PR, approved for treatment of chronic angina in 56 countries and currently marketed in 21 countries including the US shows clinical efficacy and tolerability in the proposed therapeutic dose range from 375 mg to 750mg. Factors that may affect ranolazine pharmacokinetics including demographics, drug-drug interactions, disease state, CYP2D6 metabolizer genotype status and impaired renal or hepatic functions have been studied. The relationship between ranolazine plasma concentration and clinical effects has been also well-established. This PK study has been designed as a bridging study for Ranolazine PR registration in Korea.

Conditions

• Healthy Male Individuals

Interventions

Type	Name	Description
DRUG	Ranolazine

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-07-01
• Completion: 2016-10-01
• First posted: 2016-06-29
• Last updated: 2016-06-29

Locations

1 site across 1 country: South Korea