NCT06830954

Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, open-label, randomized, two-sequence, four-period, crossover bioequivalence study. The study is mainly divided into two stages: screening period (2 weeks) and treatment period (4 weeks). Washout time is 7 days.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Group A	Drug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg).
DRUG	Reference Group	Drug: Fluvastatin sodium extended release tablet, 80 mg Period 1 and 3, the participants randomly received single oral dose of reference drug ( Fluvastatin sodium extended release tablet 80 mg). Period 2 and 4, the participants randomly received single oral dose of test drug ( Fluvastatin sodium extended release tablet 80 mg).

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-05-01
• Completion: 2025-12-01
• First posted: 2025-02-17
• Last updated: 2025-02-17