A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions
This study has been completed.
Sponsor:
Paddock Laboratories, Inc.
Information provided by:
Paddock Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00990301
First received: October 4, 2009
Last updated: October 6, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. Drug: Uniretic® 15mg/25mg Tablets |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Paddock Laboratories, Inc.:
Primary Outcome Measures:
- Bioequivalence according to US FDA guidelines [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets | Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc. |
| Active Comparator: Uniretic® 15mg/25mg Tablets | Drug: Uniretic® 15mg/25mg Tablets |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990301
Locations
| United States, Pennsylvania | |
| Novum Pharmaceutical Research Services | |
| Pittsburg, Pennsylvania, United States, 15206 | |
Sponsors and Collaborators
Paddock Laboratories, Inc.
Investigators
| Principal Investigator: | Kennedy, M.D. | Novum Pharmaceutical Research Services |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00990301 History of Changes |
| Other Study ID Numbers: | 10630201 |
| Study First Received: | October 4, 2009 |
| Last Updated: | October 6, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Paddock Laboratories, Inc.:
|
Healthy Subjects Bioequivalence |
Additional relevant MeSH terms:
|
Hydrochlorothiazide Moexipril Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013