NCT00865176

Brief Summary

The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1 hypertension

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

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

March 18, 2009

Last Update Submit

March 27, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines

    10 days

Study Arms (2)

1

EXPERIMENTAL

Eplerenone 50mg Tablets

Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA

2

ACTIVE COMPARATOR

INSPRA 50mg Tablets

Drug: Inspra 50 mg Tablets GD Searle LLC, USA

Interventions

Eplerenone 50 mg Tablets Sandoz Inc., USADRUG
1
Inspra 50 mg Tablets GD Searle LLC, USADRUG
2

Eligibility Criteria

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

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Deepen Patel, M.D., CCFP

    Allied Research International Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

June 1, 2006

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 29, 2017

Record last verified: 2009-03