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

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ClinicalTrials.gov Identifier: NCT01083290
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : May 10, 2010
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: Spironolactone Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets in Healthy Subjects Under Fasting Conditions.
Study Start Date : April 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083290


Locations
India
Accutest Research Laboratories (I) Pvt. Ltd.
Mumbai, India, 400709
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Suhas Khandave, MD Accutest Research Laboratories (I) Pvt. Ltd.

Responsible Party: Ulla Sairanen/ Clinical Study Manager, Orion Corporation Orion Pharma
ClinicalTrials.gov Identifier: NCT01083290     History of Changes
Other Study ID Numbers: 0300012
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: May 2010

Keywords provided by Orion Corporation, Orion Pharma:
spironolactone
linearity of pharmacokinetics
Healthy volunteers

Additional relevant MeSH terms:
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents