Status:
COMPLETED
Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
18-50 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00776139
Start Date
October 1 2004
End Date
December 1 2004
Last Update
October 20 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bioanalytical Systems, Inc.
Baltimore, Maryland, United States, 21201