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

Orion Corporation, Orion Pharma14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

SpironolactoneDRUG

single dose of one tablet; 25 mg tablet

SpironolactoneDRUG

single dose of one tablet; 50 mg tablet

SpironolactoneDRUG

single dose of one tablet; 100 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Accutest Research Laboratories (I) Pvt. Ltd.

Mumbai, India

Outcomes

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

Data from ClinicalTrials.gov

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