A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Non-fasting Conditions

NCT ID: NCT00863902

Last Updated: 2010-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2006-09-30

Brief Summary

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

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 Fed 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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Cetirizine Hydrochloride

Cetirizine Hydrochloride 10 mg tablets, single dose

Group Type: EXPERIMENTAL

Cetirizine Hydrochloride 10 mg tablets, single dose

Intervention Type: DRUG

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

Zyrtec

Zyrtec® 10 mg tablets, single dose

Group Type: ACTIVE_COMPARATOR

Zyrtec® 10 mg tablets, single dose

Intervention Type: DRUG

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

Interventions

Cetirizine Hydrochloride 10 mg tablets, single dose

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

Intervention Type: DRUG

Zyrtec® 10 mg tablets, single dose

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

Intervention Type: DRUG

Other Intervention Names

Cetirizine; Cetirizine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Evin H. Sides III,, MD

Role: PRINCIPAL_INVESTIGATOR

AAI Clinic (AAIPharma Inc.)

Locations

AAIPharma Inc.- AAI Clinic

Morrisville, North Carolina, United States

Countries

United States

Other Identifiers

AAI-US-431

Identifier Type: -

Identifier Source: org_study_id