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Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834067
First Posted: February 3, 2009
Last Update Posted: September 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceuticals USA
  Purpose
The objective of this study is to compare the relative bioavailability of moexipril HCl/ hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult, non-smoking subjects under non-fasting conditions.

Condition Intervention Phase
Healthy Drug: Moexipril HCl/hydrochlorothiazide 15/25 mg tablets Drug: UNIRETIC® 15/25 mg tablets Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Relative Bioavailability Study of Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril. [ Time Frame: Blood samples collected over a 192 hour period. ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril. [ Time Frame: Blood samples collected over a 192 hour period. ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril. [ Time Frame: Blood samples collected over a 192 hour period. ]
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide. [ Time Frame: Blood samples collected over a 192 hour period. ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide. [ Time Frame: Blood samples collected over a 192 hour period. ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide. [ Time Frame: Blood samples collected over a 192 hour period. ]

Secondary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat. [ Time Frame: Blood samples collected over a 192 hour period. ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat. [ Time Frame: Blood samples collected over a 192 hour period. ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat. [ Time Frame: Blood samples collected over a 192 hour period. ]

Enrollment: 60
Study Start Date: October 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Moexipril HCl/hydrochlorothiazide 15/25 mg tablets
1 x 15/25 mg
Active Comparator: 2 Drug: UNIRETIC® 15/25 mg tablets
1 x 15/25 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects selected for this study will be non-smokers at least 18 years of age.
  • Subjects will have a BMI index (body mass index) of 30 or less.

Exclusion Criteria:

  • Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result not to be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
  • All subjects will have urine samples assayed for the presence of abuse as part of the clinical laboratory screening procedures and ath check-in each study period. Subjects found to have urine concentrations of any of the tested drug will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken an investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
  • All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834067


Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
United States, Texas
Bioassay Laboratory, Inc.
Houston, Texas, United States, 77099
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Irwin Plisco, M.D. Gateway Medical Research
  More Information

ClinicalTrials.gov Identifier: NCT00834067     History of Changes
Other Study ID Numbers: B036544
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: July 2, 2009
Results First Posted: August 18, 2009
Last Update Posted: September 11, 2009
Last Verified: September 2009

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Moexipril
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors