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
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