Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579053
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Bioequivalence Study of Spironolactone Tablets in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomized Single-dose Two-period Crossover Design on Evaluating the Bioequivalence of Spironolactone Tablets 100mg by SPH Sine Pharmaceutical Laboratories CoLtd and ALDACTONE Tablets 100mg by GD SEARLE LLC in Healthy Adult Volunteers Under Fasting and Fed Conditions
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to Evaluate the Bioequivalence of Spironolactone Tablets 100mg by SPH Sine Pharmaceutical Laboratories CoLtd 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None