Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01064102
First received: February 4, 2010
Last updated: February 5, 2010
Last verified: February 2010
  Purpose

A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fasting Conditions.


Condition Intervention Phase
Healthy
Drug: Cetirizine Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg in Healthy Adult Human Male Subjects Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2006
Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetirizine
Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys Laboratories Limited
Drug: Cetirizine Hydrochloride
Cetirizine Hydrochloride Tablets 10 mg
Other Name: Zyrtec Tablets 10 mg
Active Comparator: Zyrtec
Zyrtec Tablets 10 mg of Pfizer Labs
Drug: Cetirizine Hydrochloride
Cetirizine Hydrochloride Tablets 10 mg
Other Name: Zyrtec Tablets 10 mg

Detailed Description:

Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Cross Over, and Comparative Oral Bioavailability study in healthy, adult, human, male subjects under Fasting Conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
  2. Having a Body Mass Index (BMI) between 18.5 and 24.9 {both inclusive), calculated as weight in kg/height in m2
  3. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
  4. Able to comply with the study procedures, in the opinion of the investigator.
  5. Able to give written consent for participation in the trial.

Exclusion Criteria:

  1. Known hypersensitivity or idiosyncratic reaction to cetirizine or any other related drugs.
  2. Any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
  3. 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
  4. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
  5. 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.
  6. Smokers, who smoke more than 10 cigarettes / day or inability to abstain from smoking during the study.
  7. The presence of clinically significant abnormal laboratory values during screening.
  8. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
  9. History of psychiatric disorders.
  10. A history of difficulty in donating blood.
  11. 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.

  12. A positive hepatitis screen including hepatitis B surface antigen, Anti- HCV and Anti HAV antibodies.
  13. A positive test result for HIV antibody and/or syphilis.
  14. 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.

  15. 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01064102

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Charu Gautam, MD Lambda Therapeutic Research Ltd, Ahmedabad - 380 054, Gujarat, INDIA
  More Information

No publications provided

Responsible Party: Senior Manager - Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01064102     History of Changes
Other Study ID Numbers: 007-06
Study First Received: February 4, 2010
Last Updated: February 5, 2010
Health Authority: United States: Food and Drug Administration

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 October 19, 2014