NCT01083290

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 10, 2010

Status Verified

May 1, 2010

Enrollment Period

Same day

First QC Date

March 8, 2010

Last Update Submit

May 7, 2010

Conditions

Healthy

Keywords

spironolactonelinearity of pharmacokineticsHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Cmax, AUC0-t and AUC0-inf of Spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone in plasma

    up to 72 h after the study drug administration

Study Arms (3)

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

EXPERIMENTAL
Drug: Spironolactone

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

EXPERIMENTAL
Drug: Spironolactone

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

EXPERIMENTAL
Drug: Spironolactone

Interventions

SpironolactoneDRUG

single dose of one tablet; 25 mg tablet

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with normal findings as determined by baseline history, physical examination and vital signs, haemogram, biochemistry, infectious disease screening, urinalysis, 12 lead ECG

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accutest Research Laboratories (I) Pvt. Ltd.

Mumbai, 400709, India

Location

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Suhas Khandave, MD

    Accutest Research Laboratories (I) Pvt. Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 9, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 10, 2010

Record last verified: 2010-05

Locations

IN(1)