Bioequivalence Study of Benazepril HCl / Hydrochlorothiazide 20 mg/ 25 mg Tablets Under Fed Conditions

NCT00778674 | Completed DMC

• 1 other identifier: AAI-US-260
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine the bioavailability of Benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Conditions

Healthy

Keywords

Bioequivalence Benazepril HCl Hydrochlorothiazide Tablets

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets

Drug: Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets

2

ACTIVE COMPARATOR

Lotensin® HCT tablets

Drug: Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets

Interventions

Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• Healthy Subjects at least 18 years of age..
• Informed of the nature of the study and given written informed consent.
• Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables weighing at least 110 pounds.

You may not qualify if:

• \- Hypersensitivity to Benazepril (Lotensin®) or thiazide diuretics such as hydrochlorothiazide (Oretic® and Hydro Diuril®).
• Any history of clinical condition that might affect drug absorption, metabolism or excretion.
• Recent history (within one year) of mental illness, drug addiction, drug abuse or alcoholism.
• Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
• Received an investigational drug within the past 4 weeks prior to study dosing.
• Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
• Regular smoking of more than 5 cigarettes daily use of nicotine-containing products beginning 3 months before study medication administration through the final evaluation.
• If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and /or her partner are: oral contraceptives, progestin injection or implant, condom with spermacide, diaphragm with spermicide, IUD, vaginal spermicide Suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
• Alcohol, grapefruit beverages or foods or caffeine beverages or foods beginning 1 day before each study medication administration through each study confinement period. Such restricted items include coffee, tea, iced tea, coke®, Pepsi®, Mountain Dew®, Chocolate, brownies, etc.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

aaiPharma, Inc.

Chapel Hill, North Carolina, 27517, United States

Location

Related Links

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MeSH Terms

Interventions

benazepril; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: October 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: December 1, 2004
• Last Updated: October 23, 2008

Record last verified: 2008-10

Locations

US (1)