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Clinical trial

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

NCT06579053 is registered in ClinicalTrials.gov with SPH Sine Pharmaceutical Laboratories Co., Ltd. as lead sponsor.

NCT NCT06579053
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
SPH Sine Pharmaceutical Laboratories Co., Ltd.
Phase
Phase 1
Overall status
Completed
Start date
March 22, 2023
Completion date
August 23, 2023
Enrollment
64 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalence study