NCT01083290

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Spironolactone	single dose of one tablet; 25 mg tablet
DRUG	Spironolactone	single dose of one tablet; 50 mg tablet
DRUG	Spironolactone	single dose of one tablet; 100 mg tablet

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-03-09
• Last updated: 2010-05-10

Locations

1 site across 1 country: India