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

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.

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 of Doxazosin Extended-Release for PTSD: Findings and Recommendations for Future Research on Doxazosin

2018 ◽  
Vol 16 (1) ◽  
pp. 67-73 ◽  
Author(s):  
Anne Richards ◽  
Sabra Inslicht ◽  
Leslie Micaela Ruoff ◽  
Thomas James Metzler ◽  
Lizabeth Alexandra Goldstein ◽  
...  
Keyword(s):  
Extended Release ◽  
Future Research ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

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.

Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open-label study

2020 ◽  
Vol 5 (10) ◽  
pp. 918-926 ◽  
Author(s):  
Eric Lawitz ◽  
Charles S Landis ◽  
Steven L Flamm ◽  
Maurizio Bonacini ◽  
Grisell Ortiz-Lasanta ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Renal Impairment ◽  
Severe Renal Impairment ◽  
Genotype 1 ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Multicentre Phase

Safety and efficacy of switching to tenofovir alafenamide (TAF) in virally suppressed chronic hepatitis B (CHB) patients with renal impairment: week 48 results from a phase 2 open label study

2020 ◽  
Vol 73 ◽  
pp. S868-S869
Author(s):  
Harry Janssen ◽  
Pietro Lampertico ◽  
Chi-Yi Chen ◽  
Jeong Heo ◽  
Claire Fournier ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Renal Impairment ◽  
Chronic Hepatitis B ◽  
Phase 2 ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Safety And Efficacy ◽  
Tenofovir Alafenamide

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 Repeat administration of triamcinolone acetonide extended-release affords consistent, clinically relevant improvements in pain: results from a phase 3B, single-arm, open-label study

2019 ◽  
Vol 27 ◽  
pp. S505-S506
Author(s):  
A. Gomoll ◽  
A. Spitzer ◽  
J.C. Richmond ◽  
V.B. Kraus ◽  
D.G. Jones ◽  
...  
Keyword(s):  
Triamcinolone Acetonide ◽  
Extended Release ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Repeat Administration

Extended release levodopa at bedtime as a treatment for nocturiain Parkinson's disease: An open label study

2020 ◽  
Vol 410 ◽  
pp. 116625 ◽  
Author(s):  
Livia Brusa ◽  
Viviana Ponzo ◽  
Alessandro Stefani ◽  
Roberto Ceravolo ◽  
Giovanni Palermo ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Extended Release ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals An Open-Label Study of Guanfacine Extended Release for Traumatic Stress Related Symptoms in Children and Adolescents

2013 ◽  
Vol 23 (4) ◽  
pp. 244-251 ◽  
Author(s):  
Daniel F. Connor ◽  
Damion J. Grasso ◽  
Michelle D. Slivinsky ◽  
Geraldine S. Pearson ◽  
Alok Banga
Keyword(s):  
Children And Adolescents ◽  
Traumatic Stress ◽  
Extended Release ◽  
Open Label ◽  
Open Label Study ◽  
Label Study
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