Combined effects of maternal exposure to fungicides on behavioral development in F 1 ‐generation mice: 3. Fixed‐dose study of imazalil

2021 ◽  
Author(s):  
Toyohito Tanaka ◽  
Jin Suzuki ◽  
Akiko Inomata ◽  
Takako Moriyasu
Keyword(s):  
Behavioral Development ◽  
Maternal Exposure ◽  
Fixed Dose ◽  
Combined Effects ◽  
Dose Study

Combined effects of maternal exposure to fungicides on behavioral development in F 1 ‐generation mice: 2. Fixed‐dose study of thiabendazole

2020 ◽  
Vol 112 (20) ◽  
pp. 1809-1824
Author(s):  
Toyohito Tanaka ◽  
Toshinari Suzuki ◽  
Akiko Inomata ◽  
Takako Moriyasu
Keyword(s):  
Behavioral Development ◽  
Maternal Exposure ◽  
Fixed Dose ◽  
Combined Effects ◽  
Dose Study

scholarly journals 170 Efficacy and Safety of Dasotraline in Adults with Binge-Eating Disorder: A Randomized, Double-blind, Fixed-dose Trial

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 308-309
Author(s):  
Joyce Tsai ◽  
Brad Navia ◽  
Susan L McElroy ◽  
James I Hudson ◽  
Carlos M. Grilo ◽  
...  
Keyword(s):  
Eating Disorder ◽  
Adverse Events ◽  
Binge Eating ◽  
Binge Eating Disorder ◽  
Dry Mouth ◽  
Fixed Dose ◽  
Type I ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Dose Study

Abstract:Background:Dasotraline is a long-acting dopamine/norepinephrine reuptake inhibitor with a PK profile characterized by slow absorption and a t½ of 47-77 hours, permitting once-daily dosing. In a previous flexible dose study, dasotraline demonstrated significant efficacy in the treatment of binge-eating disorder (BED). The aim of this confirmatory fixed-dose study was to evaluate efficacy and safety of dasotraline in the treatment of patients with BED.Methods:Patients meeting DSM-5 criteria for BED were randomized to 12 weeks of double-blind treatment with dasotraline (4 mg/d or 6 mg/d), or placebo. The primary efficacy endpoint was change in number of binge-eating days per week at week 12. Secondary efficacy endpoints included changes at Week 12 on the Binge Eating Clinical Global Impression of Severity Scale (BE-CGI-S), the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE), and the proportion of patients with 100% cessation of binge-eating episodes during the final 4 weeks of treatment. Efficacy was assessed using an MMRM analysis (and a logistic regression model for cessation) with a pre-specified sequential testing procedure used to control overall type I error rate.Results:A total of 486 were in the ITT population (dasotraline 6 mg/d (N=162), 4 mg/d (N=161), or placebo (N=163). At week 12, treatment with dasotraline was associated with significant reduction in number of binge-eating days per week in the 6 mg/d group vs. placebo (-3.5 vs. -2.9; P=0.0045), but non-significant improvement in the 4 mg/d group vs. placebo (-3.2; P=0.12). Greater improvement was observed vs. placebo for dasotraline 6 mg/d and 4 mg/d, respectively, on the BE-CGI-S (P<0.01 and P<0.03) and the Y-BOC-BE (P<0.001 and P<0.02; all P-values were nominal, not adjusted for multiplicity). The proportion of patients who achieved 4-week cessation of binge-eating episodes was only significant for the dasotraline 6 mg in the completer population (P<0.05; post-hoc analysis) but was not significant for either dose of dasotraline vs. placebo when drop-outs were included in the analysis. The most common adverse events on dasotraline 6 mg/d and 4 mg/d were combined insomnia (early, middle, late), dry mouth, headache, decreased appetite, nausea, and anxiety. Changes in systolic and diastolic blood pressure were minimal. Mean baseline to endpoint changes in supine pulse rate on dasotraline 6 mg/d and 4 mg/d vs. placebo was +6.2 bpm and +4.8 vs. +0.2 bpm.Conclusions:In this 12-week, placebo-controlled, fixed-dose study, treatment with dasotraline 6 mg/d was associated with a significant reduction in frequency of binge-eating days per week; efficacy was not demonstrated for the 4 mg dose. Treatment with both doses of dasotraline resulted in improvement in the Y-BOCS-BE and the BE-CGI-S. Dasotraline was safe and generally well-tolerated at both doses; most common adverse events were insomnia, dry mouth and headache.Clinicaltrials.gov: NCT03107026Funding Acknowledgements:Supported by funding from Sunovion Pharmaceuticals Inc.

A phase I escalating single-dose and weekly fixed-dose study of cetuximab pharmacokinetics in Japanese patients with solid tumors

2009 ◽  
Vol 64 (3) ◽  
pp. 557-564 ◽  
Author(s):  
Kuniaki Shirao ◽  
Takayuki Yoshino ◽  
Narikazu Boku ◽  
Ken Kato ◽  
Tetsuya Hamaguchi ◽  
...  
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Solid Tumors ◽  
Japanese Patients ◽  
Fixed Dose ◽  
Dose Study

Differential olanzapine plasma concentrations by sex in a fixed-dose study

1999 ◽  
Vol 40 (2) ◽  
pp. 101-104 ◽  
Author(s):  
Deanna L. Kelly ◽  
Robert R. Conley ◽  
Carol A. Tamminga
Keyword(s):  
Plasma Concentrations ◽  
Fixed Dose ◽  
Dose Study

P.4.a.006 A fixed dose study of the efficacy and safety of duloxetine for the treatment of generalised anxiety disorder

2006 ◽  
Vol 16 ◽  
pp. S451 ◽  
Author(s):  
H. Koponen ◽  
C. Allgulander ◽  
Y.L. Pritchett ◽  
J. Erickson ◽  
M.J. Detke ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Generalised Anxiety Disorder ◽  
Dose Study
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