NCT07054255

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

Bioequivalence and Safety Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open-label, Single-dose, Cross-over Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-09-06
• Primary completion: 2020-11-09
• Completion: 2020-12-21
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: China