NCT00990301

Brief Summary

The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-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 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

First QC Date

October 4, 2009

Last Update Submit

November 21, 2013

Conditions

Healthy

Keywords

Healthy SubjectsBioequivalence

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence specified outcomes

Study Arms (2)

Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets

EXPERIMENTAL
Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.

Uniretic® 15mg/25mg Tablets

ACTIVE COMPARATOR
Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.Drug: Uniretic® 15mg/25mg Tablets

Interventions

Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.DRUG

test drug

Moexipril HCl/ Hydrochlorothiazide 15mg/25mg TabletsUniretic® 15mg/25mg Tablets
Uniretic® 15mg/25mg TabletsDRUG

reference drug

Uniretic® 15mg/25mg 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 assessments 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, Hydrochlorothiazide 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

moexiprilHydrochlorothiazideTablets

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDosage 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2009

First Posted

October 6, 2009

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

US(1)