HealthyPhase 1NCT00864968
Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
A Phase 1 study testing Nabumetone 750 mg tablets, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other. 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?
- Nabumetone 750 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Mar 2007
- 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.
- Availability of the subject for the entire study period and willingness to provide written informed consent after being informed of the nature of the study.
- Body mass index (BMI) between 18 and 30 kg/m2 (calculated using the BMI Calculator on the Centers for Disease Control and Prevention [CDC] website available at http://www.cdc.gov/nccdphp/dnpa/bmi/index.htm, last accessed 19 Mar 07) and a weight of at least 110 pounds.
- Good health as determined by a lack of clinically significant abnormalities in health assessments performed at Screening, as judged by the physician.
- Females were required to use a medically acceptable method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed
Who cannot join
- Hypersensitivity to nabumetone (Nabumetone) or related compounds.
- Conditions that affected the absorption, metabolism, or passage of drugs out of the body (eg, 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 > 500 mL of blood in the past 8 weeks prior to study drug dosing or difficulty in donating blood.
- Receipt of an investigational drug within the 4 weeks prior to study drug dosing.
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- Currently taking any systemic prescription medications, excluding hormone contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition did 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 was to be reviewed by the investigator prior to dosing. At the discretion of the investigator, these volunteers could be enrolled if the medication was not anticipated to alter study integrity.
- Regular smoking of more than 5 cigarettes weekly or the regular daily use of nicotinecontaining products beginning 3 months before study drug administration through the final evaluation.
- Female subjects who were lactating or had a positive pregnancy test at Screening and prior to each of the treatment periods.
- Alcohol, grapefruit beverages or foods, caffeine, or xanthine beverages or foods beginning 48 hours before each study drug administration through the last pharmacokinetic (PK) sample of each treatment period. Such restricted items included 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 drug administration.
- Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C antibody at Screening.
- Positive test results for drugs of abuse or pregnancy at Screening and prior to each study drug dosing period. Any deviation from these inclusion and exclusion criteria must have been approved by the investigator and/or the sponsor on a case-by-case basis prior to enrollment of the subject. The protocol deviation waiver must have been documented by the investigator and/or the sponsor.
- No subject was allowed to enroll in this study more than once.
Trial locations and contacts
1 site in 1 country.
United States1 site
AAIPharma Inc., AAI Clinic
Morrisville, North Carolina, 27560
About this study
The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
Read the detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 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
- Nabumetone 750 mg tablets, single dose
- Keywords
- Bioequivalence, Nabumetone, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nabumetone 750 mg tablets, single doseDrug
Also called Nabumetone
A: Experimental Subjects received Actavis Elizabeth LLC formulated products under fasting conditions
Nabumetone 750 mg tablets, single doseDrug
Also called Nabumetone
B: Active comparator Subjects received Teva formulated products under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Nabumetone 750 mg tablets, single dose Receives: Drug: Nabumetone 750 mg tablets, single dose |
| B | Active comparator | Nabumetone 750 mg tablets, single dose Receives: Drug: Nabumetone 750 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: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startFeb 2007
- Primary completionMar 2007
- Study completionMar 2007
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Evin H. Sides III, M.D., Principal investigator, AAIPharma Inc., AAI Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864968
- Sponsor's protocol ID
- AAI-US-493
- Status last verified
- Aug 2010
- First submitted
- 18 Mar 2009
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00864968
- Acronym / sponsor ID
- AAI-US-493
- Conditions
- Healthy
- Keywords
- Bioequivalence, Nabumetone, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 19 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.
The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
Detailed description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 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 |
|---|---|---|
| A | Experimental | Drug: Nabumetone 750 mg tablets, single doseNabumetone 750 mg tablets, single dose |
| B | Active comparator | Drug: Nabumetone 750 mg tablets, single doseNabumetone 750 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 (5 listed)
- Healthy subjects at least 18 years of age.
- Availability of the subject for the entire study period and willingness to provide written informed consent after being informed of the nature of the study.
- Body mass index (BMI) between 18 and 30 kg/m2 (calculated using the BMI Calculator on the Centers for Disease Control and Prevention [CDC] website available at http://www.cdc.gov/nccdphp/dnpa/bmi/index.htm, last accessed 19 Mar 07) and a weight of at least 110 pounds.
- Good health as determined by a lack of clinically significant abnormalities in health assessments performed at Screening, as judged by the physician.
- Females were required to use a medically acceptable method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed
Key exclusion criteria (15 listed)
- Hypersensitivity to nabumetone (Nabumetone) or related compounds.
- Conditions that affected the absorption, metabolism, or passage of drugs out of the body (eg, 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 > 500 mL of blood in the past 8 weeks prior to study drug 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 |
|---|---|---|
| Nabumetone 750 mg tablets, single doseAlso: NabumetoneA: Experimental Subjects received Actavis Elizabeth LLC formulated products under fasting conditions | Drug | A |
| Nabumetone 750 mg tablets, single doseAlso: NabumetoneB: Active comparator Subjects received Teva formulated products under fasting conditions | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 120 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 17 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, M.D. principal investigator
AAIPharma Inc., AAI Clinic
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 Nabumetone 750 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 5 inclusion and 15 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 17 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: 120 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 17 Aug 2010.