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

NCT00834067 | Completed Phase 1 Results

• 1 other identifier: B036544
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 non-fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (6)

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

  Bioequivalence based on Cmax.

  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.

  Bioequivalence based on AUC0-t.

  Blood samples collected over a 192 hour period.

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

  Bioequivalence based on AUC0-inf.

  Blood samples collected over a 192 hour period.

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

  Bioequivalence based on Cmax.

  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.

  Bioequivalence based on AUC0-t.

  Blood samples collected over a 192 hour period.

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

  Bioequivalence based on AUC0-inf.

  Blood samples collected over a 192 hour period.

Secondary Outcomes (3)

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

  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.

  Blood samples collected over a 192 hour period.

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

  Blood samples collected over a 192 hour period.

Study Arms (2)

1

EXPERIMENTAL

Drug: Moexipril HCl/hydrochlorothiazide 15/25 mg tablets

2

ACTIVE COMPARATOR

Drug: UNIRETIC® 15/25 mg tablets

Interventions

Moexipril HCl/hydrochlorothiazide 15/25 mg tablets DRUG

1 x 15/25 mg

1

UNIRETIC® 15/25 mg tablets DRUG

1 x 15/25 mg

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (2)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

Location

Bioassay Laboratory, Inc.

Houston, Texas, 77099, United States

Location

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Irwin Plisco, M.D.

  Gateway Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: October 1, 2003
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: August 20, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

US (2)