MedTrace Logo

Bioequivalence Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects

NCT07054255 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-07-08

No results posted yet for this study

Summary

The present study was conducted with the objective of comparing the bioequivalence and safety of a single dose of ranolazine extended-release tablets (Test product) manufactured by Haisco Pharmaceutical Group Co., Ltd. with those of the reference product (Ranexa®, Gilead Sciences, Inc.) in Chinese healthy subjects under fasting and fed conditions

Conditions

  • Healthy

Interventions

DRUG

Test formulation (Ranolazine extended-release tablets)

A single oral dose of 500 mg, taken with 240mL of water

DRUG

Reference formulation (Ranolazine extended-release tablets)

A single oral dose of 500 mg, taken with 240mL of water

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-06
Primary Completion
2020-11-09
Completion
2020-12-21

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07054255 on ClinicalTrials.gov