CompletedNCT01083290Updated May 10, 2010

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

A Phase 1 interventional study of Spironolactone and Spironolactone in Healthy, sponsored by Orion Corporation, Orion Pharma. Completed at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-10.

Sponsored by Orion Corporation, Orion Pharma · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 14
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

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 studied

Healthy

Keywords

spironolactone
linearity of pharmacokinetics
Healthy volunteers

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Exclusion Criteria:

Any condition requiring regular concomitant medication or likely to need any concomitant medication during the study.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 14 participants (actual)

Study arms

Experimental
Order of strenghts; 25 mg, 50 mg, 100 mg
Drug: Spironolactone
Experimental
Order of strenghts; 50 mg, 100 mg, 25 mg
Drug: Spironolactone
Experimental
Order of strenghts; 100 mg, 25 mg, 50 mg
Drug: Spironolactone

Interventions

DrugSpironolactone
single dose of one tablet; 25 mg tablet
DrugSpironolactone
single dose of one tablet; 50 mg tablet
DrugSpironolactone
single dose of one tablet; 100 mg tablet

What researchers measure

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

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01083290
Lead sponsor: Orion Corporation, Orion Pharma
First posted: Mar 9, 2010
Start date: Apr 2010
Primary completion: Apr 2010
Completion: Apr 2010
Last update: May 10, 2010

Study contacts

Suhas Khandave, MD

principal investigator · Accutest Research Laboratories (I) Pvt. Ltd.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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