Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions
NCT ID: NCT00776139
Last Updated: 2008-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2004-10-31
2004-12-31
Brief Summary
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Detailed Description
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Safety measures were performed throughout the study and included a physical examination, laboratory evaluation, and measurement of vital signs.
A total of 32 subjects were randomized to receive single oral dose of cetirizine hydrochloride 10 mg tablet and 31 subjects completed both the periods of the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc.
Cetirizine Hydrochloride 10 mg tablet
Bioequivalence Cetirizine Hydrochloride 10 mg tablet
2
Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs
Cetirizine Hydrochloride 10 mg tablet
Bioequivalence Cetirizine Hydrochloride 10 mg tablet
Interventions
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Cetirizine Hydrochloride 10 mg tablet
Bioequivalence Cetirizine Hydrochloride 10 mg tablet
Eligibility Criteria
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Inclusion Criteria
* Were within 18 to 29.9 kilograms/m2 per the BMI (Determination of Body Mass Index).
* Had voluntarily given written informed consent to participate in this study.
* Were of normal health as determined by medical history and physical examination of the subjects performed within 30 days prior to the commencement of the study.
* Blood chemistry, hematology, and urinalysis tests performed within 30 days prior to the start of the study must be within clinically acceptable limits upon evaluation by the Investigator.
* Subjects must have screening and check-in (each period) blood pressure and pulse rate within the protocol specified ranges.
* If female and of childbearing potential, the subject was counseled on the importance of not becoming pregnant before or during the study, and the subject had a negative pregnancy test at the pre-treatment visit.
Exclusion Criteria
* history of alcohol abuse or drug addiction requiring treatment within the last 12 months.
* Presence or history of renal impairment or chronic liver disease.
* History of jaundice (yellowing of the skin or whites of the eyes).
* Participation in an investigationaldrug study or donation of blood within 30 days prior to the start of the study.
* Known allergy or sensitivity to cetirizine (Zyrtec®), or to related drugs such as hydroxyzine (Vistaril® or Ataraxl®).
* Prescription drug use (excluding hormonal contraceptives) within 14 days prior to drug administration, each period. Subject is taking macrolide antibiotics, such as erythromycin, azithromicin, ketoconazole, or related drugs.
* Ingestion of grapefruit juice or grapefruit-containg products within 72 hours prio to drug administration, each period.
* Alcohol consumption 24 hours prior to drug administration, each period.
* Caffeine or xanthine consumption for at least 10 hours prior to drug administration, each period.
* Female subjects who are pregnant or nursing.
* Positive HIV 1, Hepatitis B surface antigen, and urine screen for drugs of abuse within 30 days prior to the start of the study.
18 Years
50 Years
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Laboratories Limited
Locations
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Bioanalytical Systems, Inc.
Baltimore, Maryland, United States
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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11821
Identifier Type: -
Identifier Source: org_study_id