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

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Moexipril HCl/hydrochlorothiazide 15/25 mg tablets (Drug); UNIRETICĀ® 15/25 mg tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Steven Herrmann, M.D.; Ph. D., Principal Investigator, Affiliation: Gateway Medical Research

Summary

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.

Clinical Details

Official title: A Relative Bioavailability Study of Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions

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

Primary outcome:

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.

Secondary outcome:

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Gateway Medical Research, Inc., St. Charles, Missouri 63301, United States

Bioassay Laboratory, Inc., Houston, Texas 77099, United States

Additional Information

Starting date: October 2003
Last updated: September 1, 2009

Page last updated: August 23, 2015

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