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To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers
The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.
HL-TOF tab. 5mg, Xeljanz tab. 5mg
Korea, Republic of
Hanlim Pharm. Co., Ltd.
Published on BioPortfolio: 2019-10-09T09:21:35-0400
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer...
Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice
The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of M...
The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice. 1) Occurrence of adverse reactions, factors that ...
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 600 patients treated in the setting of...
Although healthy volunteers often serve as controls or primary participants in neuroscience research, they are usually less rigorously screened than patients, which can have far-reaching implication...
Recent sociological research has raised important sociological and ethical questions about the role of financial rewards in terms of healthy volunteer involvement in clinical trials. Research suggests...
To characterize the microvascular effects of a brief period of hyperoxia, in patients with septic shock and in healthy volunteers.
This study evaluated the acute effect of a high-carbohydrate snack (HCS) on systemic microvascular function of healthy, young volunteers, using laser speckle contrast imaging (LSCI).
Remote ischemic preconditioning (RIP) may protect remote organs from ischemia-reperfusion-injury (IRI) in surgical and non-surgical patients. There are few data available on RIP and lung function, esp...
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.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
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...