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Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

NCT06579053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-08-30

No results posted yet for this study

Summary

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.

Conditions

  • Bioequivalence Study

Interventions

DRUG

Spironolactone Tablets (Test)

Take one test tablet each period

DRUG

Spironolactone Tablets (Reference)

Take one reference tablet each period

Sponsors & Collaborators

  • SPH Sine Pharmaceutical Laboratories Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2023-05-05
Completion
2023-08-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579053 on ClinicalTrials.gov