NCT06830954View on ClinicalTrials.gov

Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

May 31, 2025

Study Completion Date

December 31, 2025

Conditions
Bioequivalence
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).

All Listed Sponsors
lead

Shenzhen Salubris Pharmaceuticals Co., Ltd.

INDUSTRY