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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test formulation | Experimental | Ranolazine sustained-release tablets, specification: 500 mg, Haisco Pharmaceutical Co., Ltd. |
|
| Reference formulation | Experimental | Ranolazine sustained-release tablets (Ranexa®), specification: 500 mg, Gilead Sciences, Inc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation (Ranolazine extended-release tablets) | Drug | A single oral dose of 500 mg, taken with 240mL of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The pharmacokinetic parameters of Ranolazine in plasma | From the start of administration to 48 hours post-dose |
| AUC(0-t) | The pharmacokinetic parameters of Ranolazine in plasma | From the start of administration to 48 hours post-dose |
| AUC(0-∞) | The pharmacokinetic parameters of Ranolazine in plasma | From the start of administration to 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | The incidence and severity of AEs | From the time of signing ICF to the end of follow-up,up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Southeast University | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41298182 | Derived | Chen X, Li Y, Ma G. Bioequivalence and Safety Study of Ranolazine Extended-Release Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: A Randomized, Open-Label, Single-Dose, Cross-Over, Comparative Pharmacokinetic Study. Clin Ther. 2026 Jan;48(1):88-94. doi: 10.1016/j.clinthera.2025.11.002. Epub 2025 Nov 25. |
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| Reference formulation (Ranolazine extended-release tablets) | Drug | A single oral dose of 500 mg, taken with 240mL of water |
|