Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00776139
First received: October 17, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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


Condition Intervention
Healthy
Drug: Cetirizine Hydrochloride 10 mg tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2004
Study Completion Date: December 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc.
Drug: Cetirizine Hydrochloride 10 mg tablet
Bioequivalence Cetirizine Hydrochloride 10 mg tablet
Experimental: 2
Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs
Drug: Cetirizine Hydrochloride 10 mg tablet
Bioequivalence Cetirizine Hydrochloride 10 mg tablet

Detailed Description:

The study was conducted as an open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability of the test formulation of cetirizine hydrochloride tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) containing containing 10 mg cetirizine hydrochloride study comparing to the marketed product, Zyrtec®, containing 10 mg of cetirizine hydrochloride of Pfizer Labs (Division of Pfizer Inc.), in healthy, adult, human, subjects under fasting condition.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776139

Locations
United States, Maryland
Bioanalytical Systems, Inc.
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Laboratories Limited
ClinicalTrials.gov Identifier: NCT00776139     History of Changes
Other Study ID Numbers: 11821
Study First Received: October 17, 2008
Last Updated: October 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Cetirizine Hydrochloride 10 mg tablet fasting conditions

Additional relevant MeSH terms:
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014