NCT00865176

CompletedPhase 1

Comparative Bioavailability Study of Eplerenone 50 mg Tablet...

Sandoz Source

Compare

Other study identifiers

Sponsor study identifier

P1DX06002

Study Type

interventional

Actual enrollment (reported)

60

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2006

Actual (reported)

Study Completion

July 2006

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 60 participants
Study completion date: July 2006
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2006
Actual (reported)
Study Completion
July 2006
Actual (reported)
First Submitted
March 18, 2009
Actual (reported)
First Posted
March 19, 2009
Actual (reported)

Last Updated: March 29, 2017
Status Verified: March 2009
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Sandoz
Industrylead

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

Enrollment

60 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT00883506

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed

Phase 1Completed

NCT00913965

To Demonstrate the Relative Bioavailability of Atenolol Tablets

Phase 1Completed

NCT00943852

The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)

Phase 1Completed

SYF39f392fdfdff4baeba207b2bf87578e6

A randomized, single dose, cross-over bioavailability study comparing the drug-drug interaction between telmisartan tablets, indapamide tablets, and amlodipine tablets when co-administered versus the administration of each product alone in three arms to healthy volunteers under fasting conditions.

Phase 1Unknown

NCT01033318

A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)

Phase 1Completed

NCT00953680

Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

Phase 1Completed

Positive test results for HIV or hepatitis B or C.

Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Primary Completion

July 2006

Actual (reported)

Study Completion

July 2006

Actual (reported)

Last Updated

March 29, 2017

Record last verified: 2009-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00865176
Data provider: ClinicalTrials.gov
Source updated: 2017-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:53 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record