- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01064115
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg in Healthy Adult Human Male Subjects Under Fed Conditions.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 {both inclusive), calculated as weight in kg/height in m2
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
- Able to comply with the study procedures, in the opinion of the investigator.
- Able to give written consent for participation in the trial.
Exclusion Criteria:
- Known hypersensitivity or idiosyncratic reaction to cetirizine or any other related drugs.
- Any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal investigator / Medical expert
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- A recent history of alcoholism (<2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving IP.
- Smokers, who smoke more than 10 cigarettes / day or inability to abstain from smoking during the study.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History of psychiatric disorders.
- A history of difficulty in donating blood.
Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IP.
Note: In case, the blood loss was ≤200 mL; subject can be dosed 60 days after the blood donation.
- A positive hepatitis screen including hepatitis B surface antigen, Anti- HCV and Anti HAV antibodies.
- A positive test result for HIV antibody and/or syphilis.
The receipt of an investigational drug or product, or participation in a drug research study within a period of 90 days prior to the first dose of IP (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study).
Note: If subject had participated in a study in which blood loss was ≤200 mL, subject can be dosed after completion of 60 days after the last sample of the previous study.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the IP and throughout the subjects participation in the study. In any such case subject selection will be at the discretion of the Principal lnvestigator/Medical expert.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cetirizine
Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys Laboratories Limited
|
Cetirizine Hydrochloride Tablets 10 mg
Other Names:
|
Active Comparator: Zyrtec
Zyrtec Tablets 10 mg of Pfizer Labs
|
Cetirizine Hydrochloride Tablets 10 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 008-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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