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

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864968
First received: March 18, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Nabumetone 750 mg tablets, single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 120 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Nabumetone 750 mg tablets, single dose
Drug: Nabumetone 750 mg tablets, single dose
A: Experimental Subjects received Actavis Elizabeth LLC formulated products under fasting conditions
Other Name: Nabumetone
Active Comparator: B
Nabumetone 750 mg tablets, single dose
Drug: Nabumetone 750 mg tablets, single dose
B: Active comparator Subjects received Teva formulated products under fasting conditions
Other Name: Nabumetone

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864968

Locations
United States, North Carolina
AAIPharma Inc., AAI Clinic
Morrisville, North Carolina, United States, 27560
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Evin H. Sides III, M.D. AAIPharma Inc., AAI Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864968     History of Changes
Other Study ID Numbers: AAI-US-493
Study First Received: March 18, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Nabumetone
Healthy subjects

Additional relevant MeSH terms:
Nabumetone
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014