Randomized, Double‐Blind, Single‐Dose, Placebo‐Controlled Crossover Study to Evaluate the Effects of Esaxerenone on QTc Interval in Healthy Subjects

2020 ◽  
Vol 9 (6) ◽  
pp. 709-718
Author(s):  
Jeanne Mendell ◽  
Fumiaki Kobayashi ◽  
Takako Shimizu
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Subjects ◽  
Qtc Interval ◽  
Double Blind

Respiratory Safety of Lemborexant in Healthy Subjects: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Crossover Study

2021 ◽  
Author(s):  
Jocelyn Y. Cheng ◽  
Margaret Moline ◽  
Gary K. Zammit ◽  
Gleb Filippov ◽  
Mohammad Bsharat ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Subjects ◽  
Double Blind ◽  
Double Blind Placebo

A Randomized, Double‐Blind, Single‐Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants

2018 ◽  
Vol 8 (3) ◽  
pp. 361-370 ◽  
Author(s):  
Bonnie C. Shaddinger ◽  
Georgios Vlasakakis ◽  
Joseph Soffer ◽  
Karl M. Thorpe ◽  
Daniel Hatch ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Adult ◽  
Double Blind ◽  
Adult Participants

Single-Dose Comparative Pharmacokinetics of Two Formulations of Lenalidomide 25 mg in Healthy Subjects: A Randomized Crossover Study

2018 ◽  
Vol 35 (2) ◽  
pp. 210-217
Author(s):  
SeungHwan Lee ◽  
Jun Gi Hwang ◽  
Sang Yeob Park ◽  
Hye Jung Lim ◽  
Sa-Won Lee ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Subjects ◽  
Randomized Crossover Study

Comparative study of the effects of zopiclone (7.5 mg), zolpidem, flunitrazepam and a placebo on nocturnal cognitive performance in healthy subjects, in relation to pharmacokinetics

1995 ◽  
Vol 10 (S3) ◽  
pp. 129s-135s ◽  
Author(s):  
H Allain ◽  
A Patat ◽  
A Lieury ◽  
F Le Coz ◽  
C Janus ◽  
...  
Keyword(s):  
Single Dose ◽  
Visual Analogue Scale ◽  
Cognitive Performance ◽  
Healthy Subjects ◽  
Analogue Scale ◽  
Randomized Study ◽  
Residual Effect ◽  
Pharmacodynamic Effect ◽  
Double Blind ◽  
Nocturnal Period

SummaryThe effect of zopiclone (7.5 mg) on attention, vigilance and memory components was evaluated during a nocturnal period in comparison to a placebo, to zolpidem (10 mg) and to flunitrazepam (1 mg) in a double blind, randomized study, after administration of a single dose in 16 young healthy volunteers. It appears that there is a clear effect on attention and vigilance; this effect is apparent during the kinetic phase of the absorption of the medication. The effect on memory is transient and is absent four hours after the ingestion of the drug. The objective results are not strictly consistent with the chronology of the subjective parameters (Leeds scale — Visual Analogue Scale). The three hypnotics under comparison do not fundamentally differ except in their kinetic/pharmacodynamic effect relationship. One important fact, taking the parameters as a whole, is that there is no objective “residual” effect.

scholarly journals Randomised, double-blind, placebo-controlled crossover study of single-dose guanfacine in unilateral neglect following stroke

2018 ◽  
Vol 89 (6) ◽  
pp. 593-598 ◽  
Author(s):  
Edwin S Dalmaijer ◽  
Korina M S Li ◽  
Nikos Gorgoraptis ◽  
Alexander P Leff ◽  
David L Cohen ◽  
...  
Keyword(s):  
Working Memory ◽  
Single Dose ◽  
Crossover Study ◽  
Functional Outcome ◽  
Sustained Attention ◽  
Spatial Working Memory ◽  
Double Blind ◽  
Unilateral Neglect ◽  
Directional Bias ◽  
Double Blind Placebo

ObjectiveUnilateral neglect is a poststroke disorder that impacts negatively on functional outcome and lacks established, effective treatment. This multicomponent syndrome is characterised by a directional bias of attention away from contralesional space, together with impairments in several cognitive domains, including sustained attention and spatial working memory. This study aimed to test the effects of guanfacine, a noradrenergic alpha-2A agonist, on ameliorating aspects of neglect.MethodsThirteen right hemisphere stroke patients with leftward neglect were included in a randomised, double-blind, placebo-controlled proof-of-concept crossover study that examined the effects of a single dose of guanfacine. Patients were tested on a computerised, time-limited cancellation paradigm, as well as tasks that independently assessed sustained attention and spatial working memory.ResultsOn guanfacine, there was a statistically significant improvement in the total number of targets found on the cancellation task when compared with placebo (mean improvement of 5, out of a possible 64). However, there was no evidence of a change in neglect patients’ directional attention bias. Furthermore, Bayesian statistical analysis revealed reliable evidence against any effects of guanfacine on search organisation and performance on our sustained attention and spatial working memory tasks.ConclusionsGuanfacine improves search in neglect by boosting the number of targets found but had no effects on directional bias or search organisation, nor did it improve sustained attention or working memory on independent tasks. Further work is necessary to determine whether longer term treatment with guanfacine may be effective for some neglect patients and whether it affects functional outcome measures.Trial registration numberNCT00955253.

Sign in / Sign up

Export Citation Format

Share Document