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A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions

Information source: Paddock Laboratories, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. (Drug); Uniretic® 15mg/25mg Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Paddock Laboratories, Inc.

Official(s) and/or principal investigator(s):
Kennedy, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services

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.

Clinical Details

Official title: A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide 15mg/25mg Tablets (Paddock Laboratories, Inc) and Uniretic« 15mg/25mg Tablets (Schwarz Pharma)(Moexipril HCl/Hydrochlorothiazide) in Healthy Adult Volunteers Under Fasting Conditions.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence specified outcomes

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Good health as determined by lack of clinically significant abnormalities in health

assessments performed at screening Exclusion Criteria:

- Positive test results for HIV or Hepatitis B or C

- History of allergy or sensitivity to Moexipril, Hydrochlorothiazide or related drugs

Locations and Contacts

Novum Pharmaceutical Research Services, Pittsburg, Pennsylvania 15206, United States
Additional Information


Last updated: November 21, 2013

Page last updated: August 23, 2015

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