Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
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.
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: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Nabumetone 750 mg tablets, single dose, Nabumetone 750 mg tablets, single dose
Location
AAIPharma Inc., AAI Clinic
Morrisville
North Carolina
United States
27560
Status
Completed
Source
Actavis Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00864968
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lethal Dose 50
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Mice, Inbred Sencar
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
Drug Combinations
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
Maximum Tolerated Dose
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Clinical Trials
The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence
A Relative Bioavailability Study of Citalopram HBr 10 mg Tablets Under Fasting Conditions
The purpose of this study is compare the relative bioavailability of 10 mg Citalopram Hydrobromide tablets by Purepac Pharmaceutical Co with that of 10 mg CELEXATM tablets distributed and...
Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an...
A Limited Food Effect Study of Gabapentin 800 mg Tablets
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis...
A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Non-Fasting Conditions
To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fed conditions.
PubMed Articles
Effects of Nabumetone and Dipyrone on Experimentally Induced Gastric Ulcers in Rats.
Nabumetone and dipyrone are non-acidic, nonsteroidal anti-inflammatory drugs. Both of them are known to have weak inhibitory effects of cyclooxygenases. Gastric side effects represent the most common...
Determination of the scale of segregation of low dose tablets using hyperspectral imaging.
In this work, near infrared (NIR) hyperspectral imaging was used to quantify the spatial distribution of drug in tablets containing tolmetin sodium dihydrate. Hyperspectral data cubes were generated b...
OBJECTIVE: The aim of the present study was to compare the pharmacokinetic properties, bioavailability and tolerability of artesunate (AS) and amodiaquine (AQ) administered as a fixed-dose combination...
BACKGROUND: As compared with individual tablets, saxagliptin/metformin immediate release (IR) fixed-dose combination (FDC) tablets offer the potential for increased convenience, compliance, and adhere...
Compound Danshen tablets are composed of Panax notoginseng, Salvia miltiorrhiza and Borneol. The tablets are prescribed for treatment of cardiovascular diseases in China. The present study aimed at de...
