Phase 1Completed
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
- Sponsor
- SPH Sine Pharmaceutical Laboratories Co., Ltd. (Industry)
- Enrolment
- 64 enrolled
- Conditions
- Bioequivalence Study
- Interventions
- Spironolactone Tablets (Test); Spironolactone Tablets (Reference)
- Ages
- adults
- Registry
- NCT06579053
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Cmax
- AUC 0-t
- AUC 0-∞
History
Registered
Study completion
Primary completion
Started