Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets

Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets in Healthy Subjects Under Fasting Conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01083290

Enrollment

Registered

2010-03-09

Start date

2010-04-30

Completion date

2010-04-30

Last updated

2010-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

spironolactone, linearity of pharmacokinetics, Healthy volunteers

Brief summary

Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from Spironolactone 25 mg, 50 mg and 100 mg Tablets

Interventions

DRUGSpironolactone

single dose of one tablet; 25 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects with normal findings as determined by baseline history, physical examination and vital signs, haemogram, biochemistry, infectious disease screening, urinalysis, 12 lead ECG

Exclusion criteria

* Any condition requiring regular concomitant medication or likely to need any concomitant medication during the study.

Design outcomes

Primary

Measure	Time frame
Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma	up to 72 h after the study drug administration

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026