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

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Spironolactone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01083290

0300012

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Order of strenghts; 25 mg, 50 mg, 100 mg

Experimental group

Treatment:

Drug: Spironolactone

Drug: Spironolactone

Drug: Spironolactone

Order of strenghts; 50 mg, 100 mg, 25 mg

Experimental group

Treatment:

Drug: Spironolactone

Drug: Spironolactone

Drug: Spironolactone

Order of strenghts; 100 mg, 25 mg, 50 mg

Experimental group

Treatment:

Drug: Spironolactone

Drug: Spironolactone

Drug: Spironolactone