NCT00883506

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_1 hypertension

Timeline
Completed

Started May 2000

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

May 1, 2000

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

April 16, 2009

Last Update Submit

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
Lisinopril 40 mg Tablet under fed conditions.DRUG
1

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:

  • 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

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

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 1, 2000

Primary Completion

June 1, 2000

Study Completion

June 1, 2000

Last Updated

March 29, 2017

Record last verified: 2009-03