An open-label study to determine the pharmacokinetics and safety of migalastat HCl in subjects with impaired renal function and healthy subjects with normal renal function

2014 ◽  
Vol 4 (4) ◽  
pp. 256-261 ◽  
Author(s):  
Franklin K. Johnson ◽  
Paul N. Mudd ◽  
Tara DiMino ◽  
Jennie Vosk ◽  
Sheela Sitaraman ◽  
...  
Keyword(s):  
Renal Function ◽  
Normal Renal Function ◽  
Healthy Subjects ◽  
Impaired Renal Function ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals An open‐label study to estimate the effect of steady‐state erythromycin on the pharmacokinetics, pharmacodynamics, and safety of a single dose of rivaroxaban in subjects with renal impairment and normal renal function

2014 ◽  
Vol 54 (12) ◽  
pp. 1407-1420 ◽  
Author(s):  
Kenneth T. Moore ◽  
Seema Vaidyanathan ◽  
Jaya Natarajan ◽  
Jay Ariyawansa ◽  
Lloyd Haskell ◽  
...  
Keyword(s):  
Renal Function ◽  
Single Dose ◽  
Steady State ◽  
Renal Impairment ◽  
Normal Renal Function ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals A Single-Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Lisdexamfetamine Dimesylate in Individuals With Normal and Impaired Renal Function

2016 ◽  
Vol 38 (4) ◽  
pp. 546-555 ◽  
Author(s):  
James Ermer ◽  
Mary Corcoran ◽  
Kenneth Lasseter ◽  
Thomas Marbury ◽  
Brian Yan ◽  
...  
Keyword(s):  
Renal Function ◽  
Single Dose ◽  
Impaired Renal Function ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Open Label Study ◽  
Label Study

scholarly journals Preliminary Results of CitraVes™ Effects on Low Density Lipoprotein Cholesterol and Waist Circumference in Healthy Subjects after 12 Weeks: A Pilot Open-Label Study

Metabolites ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 276
Author(s):  
Stefania Raimondo ◽  
Dragana Nikolic ◽  
Alice Conigliaro ◽  
Gianluca Giavaresi ◽  
Bruna Lo Sasso ◽  
...  
Keyword(s):  
Risk Factors ◽  
Healthy Subjects ◽  
Cardiometabolic Risk ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Modifiable Risk Factors ◽  
Low Density Lipoprotein Cholesterol ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Appropriate monitoring and control of modifiable risk factors, such as the level of low-density lipoprotein cholesterol (LDL-C) and other types of dyslipidemia, have an important role in the prevention of cardiovascular diseases (CVD). Recently, various nutraceuticals with lipid-lowering effects have gained attention. In addition to the plant-derived bioactive compounds, recent studies suggested that plant cells are able to release small lipoproteic structures named extracellular vesicles (EVs). The interaction between EVs and mammalian cells could lead to beneficial effects through anti-inflammatory and antioxidant activities. The present study aimed to assess the safety of the new patented plant-based product citraVes™, containing extracellular vesicles (EVs) from Citrus limon (L.) Osbeck juice, and to investigate its ability to modulate different CV risk factors in healthy subjects. A cohort of 20 healthy volunteers was recruited in a prospective open-label study. All participants received the supplement in a spray-dried formulation at a stable dose of 1000 mg/day for 3 months. Anthropometric and hematobiochemical parameters were analyzed at the baseline and after the follow-up period of 1 and 3 months. We observed that the supplement has an effect on two key factors of cardiometabolic risk in healthy subjects. A significant change in waist circumference was found in women after 4 (85.4 [79.9, 91.0] cm, p < 0.005) and 12 (85.0 [80.0, 90.0] cm, p < 0.0005) weeks, when compared to the baseline value (87.6 [81.7, 93.6] cm). No difference was found in men (baseline: 100.3 [95.4, 105.2] cm; 4 weeks: 102.0 [95.7, 108.3] cm; 12 weeks: 100.0 [95.3, 104.7] cm). The level of LDL-C was significantly lower at 12 weeks versus 4 weeks (p = 0.0064). Our study evaluated, for the first time, the effects of a natural product containing plant-derived EVs on modifiable risk factors in healthy volunteers. The results support the use of EV extracts to manage cardiometabolic risk factors successfully.

scholarly journals Fosamprenavir plus Ritonavir Increases Plasma Ketoconazole and Ritonavir Exposure, while Amprenavir Exposure Remains Unchanged

2007 ◽  
Vol 51 (8) ◽  
pp. 2982-2984 ◽  
Author(s):  
Mary B. Wire ◽  
Charles H. Ballow ◽  
Julie Borland ◽  
Mark J. Shelton ◽  
Yu Lou ◽  
...  
Keyword(s):  
Steady State ◽  
Healthy Subjects ◽  
Open Label ◽  
Time Curve ◽  
Once Daily ◽  
Open Label Study ◽  
Label Study ◽  
Concentration Time

ABSTRACT Plasma ketoconazole (KETO), amprenavir (APV), and ritonavir (RTV) pharmacokinetics were evaluated in 15 healthy subjects after being treated with KETO at 200 mg once daily (QD), fosamprenavir (FPV)/RTV at 700/100 mg twice daily (BID), and then KETO at 200 mg QD plus FPV/RTV at 700/100 mg BID in this open-label study. The KETO area under the concentration-time curve at steady state was increased 2.69-fold with FPV/RTV. APV exposure was unchanged, and RTV exposure was slightly increased.

scholarly journals Front cover: Bioavailability of Terpenes and Postprandial Effect on Human Antioxidant Potential. An Open-Label Study in Healthy Subjects

2018 ◽  
Vol 62 (3) ◽  
pp. 1870031
Author(s):  
Efstathia Papada ◽  
Aristea Gioxari ◽  
Vincent Brieudes ◽  
Charalampia Amerikanou ◽  
Maria Halabalaki ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Antioxidant Potential ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Front Cover

scholarly journals Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study

2020 ◽  
Vol 37 (10) ◽  
pp. 4381-4395
Author(s):  
Jonathan Q. Tran ◽  
Peijin Zhang ◽  
Atalanta Ghosh ◽  
Liangang Liu ◽  
Mary Syto ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Active Metabolites ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Parallel Group

scholarly journals A Phase 1, Open-Label Study in Healthy Subjects to Evaluate the Absolute Bioavailability of AG-221 by a Microtracer Approach

2019 ◽  
Vol 8 (1) ◽  
pp. 91-102
Author(s):  
Xiaomin Wang ◽  
Jian Chen ◽  
Josephine Reyes ◽  
Simon Zhou ◽  
Maria Palmisano ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Phase 1 ◽  
Absolute Bioavailability ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
The Absolute

scholarly journals Polyvalent Human Immune Globulin: A Prospective, Open-Label Study Assessing Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety in HAV-Seronegative Healthy Subjects

2020 ◽  
Vol 37 (5) ◽  
pp. 2373-2389
Author(s):  
Martin Kankam ◽  
Rhonda Griffin ◽  
Jeffrey Price ◽  
Josée Michaud ◽  
Wei Liang ◽  
...  
Keyword(s):  
Immune Globulin ◽  
Healthy Subjects ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Human Immune ◽  
Antibody Levels

scholarly journals Pharmacokinetics of dalfampridine extended release 7.5‐mg tablets in healthy subjects and individuals with mild and moderate renal impairment: An open‐label study

2013 ◽  
Vol 54 (1) ◽  
pp. 53-60 ◽  
Author(s):  
Emil Samara ◽  
Peter Winkle ◽  
Patricia Pardo ◽  
Herbert R. Henney ◽  
Susan L. Way ◽  
...  
Keyword(s):  
Renal Impairment ◽  
Healthy Subjects ◽  
Extended Release ◽  
Moderate Renal Impairment ◽  
Open Label ◽  
Open Label Study ◽  
Label Study
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