NCT00992862

Brief Summary

The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

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

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
Last Updated

September 26, 2013

Status Verified

October 1, 2009

First QC Date

October 7, 2009

Last Update Submit

September 24, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines

Study Arms (2)

Moexipril HCl 15mg Tablets

EXPERIMENTAL
Drug: Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.

Univasc® 15mg Tablets

ACTIVE COMPARATOR
Drug: Univasc® 15mg Tablets

Interventions

Moexipril HCl 15mg Tablets, Paddock Laboratories, Inc.DRUG
Moexipril HCl 15mg Tablets
Univasc® 15mg TabletsDRUG
Univasc® 15mg Tablets

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

You may not qualify if:

  • Positive test results for HIV or Hepatitis B or C
  • History of allergy or sensitivity to Moexipril HCl or related drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Interventions

moexiprilTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Kennedy, M.D.

    Novum Pharmaceutical Research Services

    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

October 7, 2009

First Posted

October 9, 2009

Last Updated

September 26, 2013

Record last verified: 2009-10

Locations

US(1)