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

NCT01083290 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2010-05-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Suhas Khandave, MD · Accutest Research Laboratories (I) Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01083290 on ClinicalTrials.gov