Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions

NCT00776139 | Completed DMC

• 1 other identifier: 11821
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fasting condition

Conditions

Healthy

Keywords

Cetirizine Hydrochloride 10 mg tablet fasting conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc.

Drug: Cetirizine Hydrochloride 10 mg tablet

2

EXPERIMENTAL

Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs

Drug: Cetirizine Hydrochloride 10 mg tablet

Interventions

Cetirizine Hydrochloride 10 mg tablet DRUG

Bioequivalence Cetirizine Hydrochloride 10 mg tablet

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-50 years.
• 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.

You may not qualify if:

• History of clinically significant organ-system (cardiovascular, neurological, hepatic, hematopoietic, pulmonary, endocrine, or gastrointestinal) disorders, or ongoing infectious diseases.
• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Bioanalytical Systems, Inc.

Baltimore, Maryland, 21201, United States

Location

Related Links

• Related Info
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MeSH Terms

Interventions

Cetirizine; Tablets

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: December 1, 2004
• Last Updated: October 20, 2008

Record last verified: 2008-10

Locations

US (1)