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

May 7, 2010 updated by: Orion Corporation, Orion Pharma

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Mumbai, India, 400709
        • Accutest Research Laboratories (I) Pvt. Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Order of strenghts; 25 mg, 50 mg, 100 mg
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
Experimental: Order of strenghts; 50 mg, 100 mg, 25 mg
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
Experimental: Order of strenghts; 100 mg, 25 mg, 50 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 72 h after the study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Suhas Khandave, MD, Accutest Research Laboratories (I) Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

May 10, 2010

Last Update Submitted That Met QC Criteria

May 7, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0300012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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