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Bioequivalence of Spironolactone Tablets 100mg in Chinese Healthy Volunteers
NCT06579053Phase 1Completed
- Sponsor
- SPH Sine Pharmaceutical Laboratories
- Start
- Mar 2023
- Primary completion
- May 2023
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of spironolactone in edema, hypertension (HTN), primary hyperaldosteronism (PA) and 2 more (2 arms), sponsored by SPH Sine Pharmaceutical Laboratories. Primary endpoints: Maximum Plasma Concentration up to 24 hours, Area Under the Curve from time 0 to last measurable concentration up to 24 hours and 1 more. Started Mar 2023; status: completed.
02
Drugs
spironolactone
03
Conditions
edemahypertension (HTN)primary hyperaldosteronism (PA)hypokalemiaheart failure (HF)
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