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

NCT00864279 | Completed Phase 1

• 1 other identifier: AAI-US-432
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Cetirizine; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  48 hours

Study Arms (2)

A

EXPERIMENTAL

Cetirizine Hydrochloride 10 mg tablets, single dose

Drug: Cetirizine Hydrochloride 10 mg tablets, single dose

B

ACTIVE COMPARATOR

Zyrtec® 10 mg tablets, single dose

Drug: Zyrtec® 10 mg tablets, single dose

Interventions

Cetirizine Hydrochloride 10 mg tablets, single dose DRUG

A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fast conditions

Also known as: Cetirizine

A

Zyrtec® 10 mg tablets, single dose DRUG

B: Active comparator Subjects received Pfizer Inc. formulated products under fast conditions

Also known as: Cetirizine

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hypersensitivity to cetirizine hydrochloride (Zyrtec®) or related compounds.
• 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.
• Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
• A hematocrit value of ≤ 33.0 % for females and ≤ 37.0 % for males.
• Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
• Received an investigational drug within the 4 weeks prior to study dosing.
• 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.
• 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.
• 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.
• 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.
• 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.
• Positive test results for: HIV, Hepatitis B surface antigen, Hepatitis C antibody at screening.
• Positive test results for: drugs of abuse or pregnancy at screening and prior to each dosing period.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

AAIPharma Inc.- AAI Clinic

Morrisville, North Carolina, 27560, United States

Location

MeSH Terms

Interventions

Cetirizine

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Evin H. Sides III,, MD

  AAI Clinic (AAIPharma Inc.)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: August 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

US (1)