NCT06579053 is a Phase 1 clinical trial of Spironolactone Tablets (Test) in Bioequivalence Study, sponsored by SPH Sine Pharmaceutical Laboratories Co., Ltd..

Who is sponsoring NCT06579053?

NCT06579053 is sponsored by SPH Sine Pharmaceutical Laboratories Co., Ltd..

What drugs are being tested in NCT06579053?

Interventions in NCT06579053: Spironolactone Tablets (Test), Spironolactone Tablets (Reference).

What condition does NCT06579053 study?

NCT06579053 studies Bioequivalence Study.

Is NCT06579053 still recruiting?

NCT06579053 is currently completed. Last updated 30 August 2024.

Last reviewed 2024-08-30 · How we verify

NCT06579053

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

Completed Phase 1 Last updated 30 August 2024

What this trial tests

Phase 1 trial testing Spironolactone Tablets (Test) in Bioequivalence Study in 64 participants. Completed in 23 August 2023.

Timeline

22 March 2023

Primary endpoint
5 May 2023

23 August 2023

Quick facts

Lead sponsor	SPH Sine Pharmaceutical Laboratories Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	64
Start date	22 March 2023
Primary completion	5 May 2023
Estimated completion	23 August 2023
Sites	1 location across China

Drugs / interventions tested

Spironolactone Tablets (Test) — full drug profile →
Spironolactone Tablets (Reference) — full drug profile →

Conditions studied

Bioequivalence Study — all drugs for Bioequivalence Study →

Sponsor

SPH Sine Pharmaceutical Laboratories Co., Ltd. — full company profile →

Who can join

Adults 18 to 40, any sex, with Bioequivalence Study. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06579053 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SPH Sine Pharmaceutical Laboratories Co., Ltd.
Last refreshed: 30 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06579053.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing