Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Nabumetone 750 mg tablets, single dose (Drug); Nabumetone 750 mg tablets, single dose (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Actavis Inc. Official(s) and/or principal investigator(s): Evin H. Sides III, M.D., Principal Investigator, Affiliation: AAIPharma Inc., AAI Clinic
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.
Clinical Details
Official title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Rate and Extend of Absorption
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
AAIPharma Inc., AAI Clinic, Morrisville, North Carolina 27560, United States
Additional Information
NABUMETONE
Starting date: February 2007
Last updated: August 13, 2010
|