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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01083290
First received: March 8, 2010
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Spironolactone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: April 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Ulla Sairanen/ Clinical Study Manager, Orion Corporation Orion Pharma
ClinicalTrials.gov Identifier: NCT01083290     History of Changes
Other Study ID Numbers: 0300012
Study First Received: March 8, 2010
Last Updated: May 7, 2010
Health Authority: India: Drugs Controller General of India

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

Additional relevant MeSH terms:
Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013