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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Spironolactone

• Registration Number: NCT01083290
• Lead Sponsor: Orion Corporation, Orion Pharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Study Start: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-07
• Last Update Posted: 2010-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Order of strenghts; 25 mg, 50 mg, 100 mg	Spironolactone	-
Order of strenghts; 50 mg, 100 mg, 25 mg	Spironolactone	-
Order of strenghts; 100 mg, 25 mg, 50 mg	Spironolactone	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Accutest Research Laboratories (I) Pvt. Ltd.; 🇮🇳 Mumbai, India