NCT06579053

Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

An Open-label, Randomized, Single-dose, Two-period Crossover Design on Evaluating the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® Tablets 100mg (by GD SEARLE LLC) in Healthy Adult Volunteers Under Fasting and Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: SPH Sine Pharmaceutical Laboratories Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg (by SPH Sine Pharmaceutical Laboratories Co.,Ltd) and ALDACTONE® tablets 100mg (by GD SEARLE LLC) in Chinese Healthy Adult Volunteers under Fasting and Fed Conditions. It will also learn about the safety of the two drugs.

Conditions

• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Spironolactone Tablets (Test)	Take one test tablet each period
DRUG	Spironolactone Tablets (Reference)	Take one reference tablet each period

Timeline

• Start date: 2023-03-22
• Primary completion: 2023-05-05
• Completion: 2023-08-23
• First posted: 2024-08-30
• Last updated: 2024-08-30

Locations

1 site across 1 country: China