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

NCT02817932 | Unknown Phase 1

• 1 other identifier: MAKR/15/Ran-Ang/001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Male Individuals

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic assessment

  Area under the plasma concentration versus time curve (AUC)

  Up to 5 days

• Pharmacokinetic Assessment

  Plasma concentration (maximum,through, average)

  Up to 5 days

• Pharmacokinetic Assessment

  Tmax

  Up to 5 days

• Pharmacokinetic Assessment

  Half-life

  Up to 5 days

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events assessed using MedDRA

  5 days

Study Arms (5)

Group 1 (Korean, 375 mg)

EXPERIMENTAL

Group 1 (Korean, 375 mg): Ranolazine PR 375 mg

Drug: Ranolazine

Group 2 (Korean, 500 mg):

EXPERIMENTAL

Group 2 (Korean, 500 mg): Ranolazine PR 500 mg

Drug: Ranolazine

Group 3 (Korean, 750 mg):

EXPERIMENTAL

Group 3 (Korean, 750 mg): Ranolazine PR 750 mg

Drug: Ranolazine

Group 4 (Caucasian, 375mg)

EXPERIMENTAL

Group 4 (Caucasian, 375mg) : Ranolazine PR 375 mg

Drug: Ranolazine

Group 5 (Caucasian, 750mg)

EXPERIMENTAL

Group 5 (Caucasian, 750mg) : Ranolazine PR 750 mg

Drug: Ranolazine

Interventions

Ranolazine DRUG

Group 1 (Korean, 375 mg); Group 2 (Korean, 500 mg):; Group 3 (Korean, 750 mg):; Group 4 (Caucasian, 375mg); Group 5 (Caucasian, 750mg)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult Korean or Caucasian males, 19 - 45 years of age
• Korean subjects: first generation of Korean subject born in Korea, both parents and the four grandparents must be of Korean origin. Proof of Korean ethnicity will be documented by medical interview and appropriate materials (e.g. Korean passport, Korean resident card) will be retained in the subject's folder
• Caucasian subjects: first generation of Caucasian subject, both parents and the four grandparents of European descent. Documentation of ethnicity will be by medical interview and by appropriate materials (e.g. passport, birth certificate(if not available, a signed affirmation by the subjects)) will be retained in the subject's folder
• Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit
• Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results
• Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study

You may not qualify if:

• History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
• Relevant chronic or acute infections
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Administration of any investigational products within 3 months from the first dose of the study drug (ranolazine PR)
• History of participating other BE study or clinical trial within 3 months from the first dose of the study drug(ranolazine PR)
• Any of the following vital sign abnormalities
• Systolic blood pressure: \<90 mmHg or \>140 mmHg
• Diastolic blood pressure: \<50 mmHg or \> 90 mmHg
• Pulse rate: \<50 bpm or \>90 bpm
• Any of the following ECG abnormalities
• PR \> 210 msec
• QRS complex \> 120 msec
• QTcF \> 430 msec
• Any finding in the physical examination deviating from normal and judged clinically significant by the investigator

Sponsors & Collaborators

• A.Menarini Asia-Pacific Holdings Pte Ltd: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Yoo H, Lee SW, Yoon DY, Yoon SH, Cho JY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Safety of Extended-release Ranolazine in Korean and White Healthy Subjects. Clin Ther. 2021 Mar;43(3):526-534.e4. doi: 10.1016/j.clinthera.2021.01.005. Epub 2021 Jan 29.

  PMID: 33518355 DERIVED

MeSH Terms

Interventions

Ranolazine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• In-Jin Jang, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

In-Jin Jang, MD

CONTACT

: +82 2 2072 1910

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: June 29, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)