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Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00835042
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 18, 2009
Last Update Posted : September 11, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

January 30, 2009
February 3, 2009
July 2, 2009
August 18, 2009
September 11, 2009
October 2003
November 2003   (Final data collection date for primary outcome measure)
  • 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. ]
Bioequivalence based on Cmax and AUC [ Time Frame: 1 month ]
Complete list of historical versions of study NCT00835042 on ClinicalTrials.gov Archive Site
  • 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. ]
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Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions
A Relative Bioavailability Study of Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions
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 fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Moexipril HCl/hydrochlorothiazide 15/25 mg tablets
    1 x 15/25 mg
  • Drug: UNIRETIC® 15/25 mg tablets
    1 x 15/25 mg
  • Experimental: 1
    Intervention: Drug: Moexipril HCl/hydrochlorothiazide 15/25 mg tablets
  • Active Comparator: 2
    Intervention: Drug: UNIRETIC® 15/25 mg tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
November 2003
November 2003   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00835042
B036543
No
Not Provided
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Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Steven Herrmann, M.D.; Ph. D. Gateway Medical Research
Teva Pharmaceuticals USA
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP