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To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
Covance Clinical Research Unit - Austin
Purdue Pharma LP
Published on BioPortfolio: 2014-08-27T03:14:44-0400
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodo...
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at...
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at...
There is a clinical need for potent opioids that produce little or no respiratory depression. In the current study we compared the respiratory effects of tapentadol, a mu-opioid receptor agonist and n...
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Semisynthetic derivative of CODEINE that acts as a narcotic analgesic more potent and addicting than codeine.
Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)
Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
A system of therapeutics founded by Samuel Hahnemann (1755-1843), based on the Law of Similars where "like cures like". Diseases are treated by highly diluted substances that cause, in healthy persons, symptoms like those of the disease to be treated. The dilutions are repeated so many times that there is less than one molecule per dose and it is suggested that benefit is from the energetic life force of the original substance.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...