Clinical Trial

Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants

Not Yet Recruiting Phase 1
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Record status
This record was last updated February 17, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd. and the reference preparation (80 mg) manufactured by Beijing Novartis Pharma Co., Ltd. in healthy participants under fasting and fed conditions.
Trial Details
NCT Number NCT06830954
Lead Sponsor Shenzhen Salubris Pharmaceuticals Co., Ltd.
Conditions Bioequivalence
Enrollment 110 participants
Start Date 2025-02
Primary Completion 2025-05 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-02-17