Clinical trial NCT00835042: Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility 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.

Primary outcomes:
measure: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.
timeFrame: Blood samples collected over a 192 hour period.
measure: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.
timeFrame: Blood samples collected over a 192 hour period.
measure: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.
timeFrame: Blood samples collected over a 192 hour period.
measure: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.
timeFrame: Blood samples collected over a 192 hour period.
measure: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.
timeFrame: Blood samples collected over a 192 hour period.
measure: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.
timeFrame: Blood samples collected over a 192 hour period.
Secondary outcomes:
measure: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.
timeFrame: Blood samples collected over a 192 hour period.
measure: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.
timeFrame: Blood samples collected over a 192 hour period.
measure: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.
timeFrame: Blood samples collected over a 192 hour period.
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
city: Houston
country: United States
facility: Bioassay Laboratory, Inc.
state: Texas
Study officials:
affiliation: Gateway Medical Research
name: Steven Herrmann, M.D.; Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: