NCT00883506

CompletedPhase 1

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x...

Sandoz Source

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Other study identifiers

Sponsor study identifier

00104

Study Type

interventional

Actual enrollment (reported)

24

Locations

0 countries

Sites

N/A

Timeline

Study Start

May 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2000

Actual (reported)

Study Completion

June 2000

Actual (reported)

Brief Summary

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

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): 24 participants
Study completion date: June 2000
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
May 2000
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2000
Actual (reported)
Study Completion
June 2000
Actual (reported)
First Submitted
April 16, 2009
Actual (reported)
First Posted
April 17, 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 based on AUC and Cmax
50 days

Study Arms (3)

1

EXPERIMENTAL

Lisinopril 40 mg Tablet under fed conditions.

Drug: Lisinopril 40 mg Tablet under fed conditions.

2

ACTIVE COMPARATOR

Lisinopril 40 mg Tablet (Zestril)

Drug: Lisinopril 40 mg Tablet (Zestril) under fed conditions.

3

EXPERIMENTAL

Lisinopril 40 mg Tablet under fasting conditions.

Drug: Lisinopril 40 mg Tablet under fasting conditions.

Interventions

Lisinopril 40 mg Tablet (Zestril) under fed conditions.Drug

2

Lisinopril 40 mg Tablet under fasting conditions.Drug

3

Eligibility Criteria

Age18 Years - 55 Years

Sexmale

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

LisinoprilTablets

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsDosage FormsPharmaceutical Preparations

Study Officials

Eric Masson, Pharm.D.
Anapharm
PRINCIPAL INVESTIGATOR

Enrollment

24 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

April 16, 2009

First Posted

April 17, 2009

Study Start

May 2000

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1Completed

NCT00913965

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Phase 1Completed

NCT01491919

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Phase 1Completed

NCT00953680

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

Phase 1Completed

NCT00223717

Treatment of Supine Hypertension in Autonomic Failure

Phase 1Completed

NCT00345150

Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls

Phase 1Completed

Lisinopril 40 mg Tablet under fed conditions.

Drug

1

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

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

June 2000

Actual (reported)

Study Completion

June 2000

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: NCT00883506
Data provider: ClinicalTrials.gov
Source updated: 2017-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:56 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 (3)

1

2

3

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