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The study is designed to evaluate the effect of food on typical blood levels obtained after oral dosing of AG-013736. Drug levels in blood will be compared after an overnight fast and a high-fat, high-calorie meal.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
AG-013736, AG-013736, AG-013736, AG-013736, AG-013736, AG-013736
Pfizer Investigational Site
Published on BioPortfolio: 2014-08-27T03:21:32-0400
To allow continuation of treatment of patients experiencing benefit from AG 013736
The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed condit...
This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.
This study is being done to find out the good and bad effects of an investigational drug that is not approved for sale, called AG-013736. Tumors need blood vessels in order to continue to...
The pharmacokinetics (PK) of β-lactam antibiotics in cystic fibrosis (CF) patients has been compared with that in healthy volunteers for over four decades; however, no quantitative models exist that ...
As with all early-stage testing of investigational drugs, clinical trials targeting HIV/AIDS can pose unknown risks to research subjects. Unlike sick participants seeking a therapeutic benefit, the mo...
Understanding the pharmacokinetics in cystic fibrosis (CF) patients is important for dosing. For antibiotics with extensive metabolism, however, a comparison of metabolite formation and elimination be...
There is limited research on healthy volunteers' perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers' inv...
To investigate differences in gait variability induced by two different single-dose opioid formulations and an inert placebo in healthy volunteers and knee osteoarthritis patients.
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.
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
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...