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NOT YET RECRUITING
NCT06830954
PHASE1

Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants

Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-02

Completion Date

2025-12

Last Updated

2025-02-17

Healthy Volunteers

Yes

Conditions

Interventions

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).