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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Accutest Research Laboratories (I) Pvt. Ltd.

Mumbai, 400709, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spironolactone

Drug

single dose of one tablet; 25 mg tablet

Primary outcomes

Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma

Time frame: up to 72 h after the study drug administration

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Mar 9, 2010
Registry last updated: May 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed