A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864279
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations after administration of single doses to normal healthy subjects under fasted conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.


Condition Intervention Phase
Healthy
Drug: Cetirizine Hydrochloride 10 mg tablets, single dose
Drug: Zyrtec® 10 mg tablets, single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Cetirizine Hydrochloride 10 mg tablets, single dose
Drug: Cetirizine Hydrochloride 10 mg tablets, single dose
A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fast conditions
Other Name: Cetirizine
Active Comparator: B
Zyrtec® 10 mg tablets, single dose
Drug: Zyrtec® 10 mg tablets, single dose
B: Active comparator Subjects received Pfizer Inc. formulated products under fast conditions
Other Name: Cetirizine

Detailed Description:

Study Type: Interventional Study Design: Single-dose two-way, crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test (Treatment A) and study reference (Treatment B).

Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy subjects at least 18 years of age.
  2. Informed of the nature of the study and provide their written informed consent.
  3. Have a body mass index2 between 18 and 30 and weighing at least 110 pound.
  4. In good health as determined by lack of clinically significant abnormalities in health assessments performed at screening as judged by the physician.

Exclusion Criteria:

  1. Hypersensitivity to cetirizine hydrochloride (Zyrtec®) or related compounds.
  2. Conditions that affect the absorption, metabolism or passage of drugs out of the body, e.g., sprue, celiac disease, Crohn's disease, colitis, liver, kidney or thyroid conditions.
  3. Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
  4. A hematocrit value of ≤ 33.0 % for females and ≤ 37.0 % for males.
  5. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
  6. Received an investigational drug within the 4 weeks prior to study dosing.
  7. Currently taking any systemic prescription medications, except for oral/cutaneous/vaginal hormone contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. Any nonprescription medication consumption reported will be reviewed by the investigator prior to dosing. At the discretion of the investigator these volunteers may be enrolled if the medication is not anticipated to alter study integrity.
  8. Regular smoking of more than 5 cigarettes weekly or the regular daily use of nicotine-containing products beginning 3 months before study medication administration through the final evaluation.
  9. If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives/patches, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal or hormonal suppository, surgical sterilization of themselves or their partner(s) or abstinence. Females taking oral contraceptives/patches must have taken them consistently for at least three months prior to receiving study medication.
  10. Grapefruit beverages or foods beginning 7 days before each study medication administration and alcohol, caffeine or xanthine beverages or foods beginning 24 hours before each study medication administration through the last PK sample of each period. Such restricted items include coffee, tea, iced tea, Coke®, Pepsi®, Mountain DeW®, chocolate, brownies, etc.
  11. Regular use of any drugs known to induce or inhibit hepatic drug metabolism (examples include barbiturates, carbamazepine, rifampin, phenylhydantoins, phenothiazines, cimetidine,omeprazole, macrolides, imidazoles, fluoroquinolones) within 30 days prior to study administration.
  12. Positive test results for: HIV, Hepatitis B surface antigen, Hepatitis C antibody at screening.
  13. Positive test results for: drugs of abuse or pregnancy at screening and prior to each dosing period.
  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: NCT00864279

Locations
United States, North Carolina
AAIPharma Inc.- AAI Clinic
Morrisville, North Carolina, United States, 27560
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Evin H. Sides III,, MD AAI Clinic (AAIPharma Inc.)
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864279     History of Changes
Other Study ID Numbers: AAI-US-432
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Cetirizine
Healthy subjects

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

ClinicalTrials.gov processed this record on October 21, 2014