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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778726 |
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 fasted subjects. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
Condition | Intervention |
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Healthy |
Drug: Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single Dose Two-Way Crossover Fasted Bioequivalence Study of Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets in Healthy Volunteers |
Enrollment: | 42 |
Study Start Date: | September 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets of Ranbaxy
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Drug: Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets |
2: Active Comparator
Lotensin® HCT tablets
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Drug: Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets |
The study was performed as a single-dose (one 20 mg/25 mg tablet), two way crossover bioequivalence study with a wash out of 7 days between doses and with equal number of subjects randomly assigned to the sequence (AB or BA) in which they received the study Test (A) and Reference (B) treatments.
Subjects were confined in the clinical facility for at least 10 hours before dosing and for 24 hours after dosing. Subjects were discharged after 24-hours blood sample and returned as outpatients for the remaining blood samples. Standardized meals were served and no caffeine, alcohol, or grapefruit-containing foods or beverages were allowed to be consumed 24 hours before dosing or throughout study confinement.
A total of 42 non-smoking subjects (24 men and 18 women) were randomized to receive single oral dose of Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg tablet and 41 subjects completed both the periods of the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research labs ( Dr. Tausif Monif ) |
Study ID Numbers: | AAI-US-256 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778726 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence benazepril and hydrochlorothiazide tablets |
Benazepril Healthy Hydrochlorothiazide |
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Protease Inhibitors Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors |