HealthyPhase 1NCT00863902
A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Non-fasting Conditions
A Phase 1 study testing Cetirizine Hydrochloride 10 mg tablets, single dose and Zyrtec® 10 mg tablets, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cetirizine Hydrochloride 10 mg tablets, single dose and Zyrtec® 10 mg tablets, single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
AAIPharma Inc.- AAI Clinic
Morrisville, North Carolina, 27560
About this study
Official title: Single Dose Two-Way Crossover Fed Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers
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.
Read the 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
- Being tested
- Cetirizine Hydrochloride 10 mg tablets, single dose, Zyrtec® 10 mg tablets, single dose
- Keywords
- Bioequivalence, Cetirizine, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine Hydrochloride 10 mg tablets, single doseDrug
Also called Cetirizine
A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions
Zyrtec® 10 mg tablets, single doseDrug
Also called Cetirizine
B: Active comparator Subjects received Pfizer Inc. formulated products under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine Hydrochloride | Experimental | Cetirizine Hydrochloride 10 mg tablets, single dose Receives: Drug: Cetirizine Hydrochloride 10 mg tablets, single dose |
| Zyrtec | Active comparator | Zyrtec® 10 mg tablets, single dose Receives: Drug: Zyrtec® 10 mg tablets, single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startAug 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Evin H. Sides III,, MD, Principal investigator, AAI Clinic (AAIPharma Inc.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863902
- Sponsor's protocol ID
- AAI-US-431
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Two-Way Crossover Fed Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00863902
- Acronym / sponsor ID
- AAI-US-431
- Conditions
- Healthy
- Keywords
- Bioequivalence, Cetirizine, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetirizine Hydrochloride | Experimental | Drug: Cetirizine Hydrochloride 10 mg tablets, single doseCetirizine Hydrochloride 10 mg tablets, single dose |
| Zyrtec | Active comparator | Drug: Zyrtec® 10 mg tablets, single doseZyrtec® 10 mg tablets, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetirizine Hydrochloride 10 mg tablets, single doseAlso: CetirizineA: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions | Drug | Cetirizine Hydrochloride |
| Zyrtec® 10 mg tablets, single doseAlso: CetirizineB: Active comparator Subjects received Pfizer Inc. formulated products under fed conditions | Drug | Zyrtec |
Primary outcome
Rate and Extend of Absorption
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evin H. Sides III,, MD principal investigator
AAI Clinic (AAIPharma Inc.)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetirizine Hydrochloride 10 mg tablets, single dose and Zyrtec® 10 mg tablets, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Extend of Absorption (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.