Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864604
First received: March 18, 2009
Last updated: August 13, 2010
Last verified: August 2010

March 18, 2009
August 13, 2010
April 2007
May 2007   (final data collection date for primary outcome measure)
Rate and Extend of Absorption [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864604 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers

The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: Single Dose Two-Way Crossover Fed 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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Nabumetone 750 mg tablets, single dose
    A: Experimental Subjects received Actavis Elizabeth LLC formulated products under fed conditions
    Other Name: Nabumetone
  • Drug: Nabumetone 750 mg tablets, single dose
    B: Active comparator Subjects received Teva formulated products under fed conditions
    Other Name: Nabumetone
  • Experimental: A
    Nabumetone 750 mg tablets, single dose
    Intervention: Drug: Nabumetone 750 mg tablets, single dose
  • Active Comparator: B
    Nabumetone 750 mg tablets, single dose
    Intervention: Drug: Nabumetone 750 mg tablets, single dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Healthy subjects at least 18 years of age.
  2. 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.
  3. 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.
  4. Good health as determined by a lack of clinically significant abnormalities in health assessments performed at Screening, as judged by the physician.
  5. 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

Exclusion Criteria

  1. Hypersensitivity to nabumetone (Nabumetone) or related compounds.
  2. 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).
  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 > 500 mL of blood in the past 8 weeks prior to study drug dosing or difficulty in donating blood.
  6. Receipt of an investigational drug within the 4 weeks prior to study drug dosing.
  7. 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.

  8. 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.
  9. Female subjects who were lactating or had a positive pregnancy test at Screening and prior to each of the treatment periods.
  10. 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.
  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 drug administration.
  12. Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C antibody at Screening.
  13. 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.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00864604
AAI-US-492
No
Meena Venugopal, Director, Clinical R&D\, Actavis Inc
Actavis Inc.
Not Provided
Principal Investigator: Evin H. Sides III, M.D. AAIPharma Inc., AAI Clinic
Actavis Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP