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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nabumetone 750 mg tablets, single dose; Drug: Nabumetone 750 mg tablets, single dose

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • AAIPharma Inc., AAI Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Nabumetone; Drug: Nabumetone 750 mg tablets, single dose; B: Active comparator Subjects received Teva formulated products under fasting conditions; Other Names: Nabumetone
Active Comparator: B; 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 Names: Nabumetone; Drug: Nabumetone 750 mg tablets, single dose; B: Active comparator Subjects received Teva formulated products under fasting conditions; Other Names: Nabumetone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	120 hours

Collaborators and Investigators

• Sponsor: Actavis Inc.
• Investigators: Principal Investigator: Evin H. Sides III, M.D., AAIPharma Inc., AAI Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Estimate): August 17, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy subjects; Nabumetone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Nabumetone
• Other Study ID Numbers: AAI-US-493