scholarly journals Pharmacokinetic and pharmacodynamic properties of a new biosimilar filgrastim TPI G-CSF in comparison to the marketed reference filgrastim Neupogen®: a double-blind, single-dose, two-period crossover trial

Biosimilars ◽  
2015 ◽  
pp. 93
Author(s):  
Andrew Bourgoin ◽  
Sarfaraz Niazi
Keyword(s):  
Single Dose ◽  
Crossover Trial ◽  
Double Blind ◽  
Biosimilar Filgrastim

scholarly journals Single-Dose Pinitol Ingestion Suppresses Post-Prandial Glucose Levels: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

2019 ◽  
Vol 14 (12) ◽  
pp. 1934578X1989081
Author(s):  
Yoshio Suzuki ◽  
Keishoku Sakuraba ◽  
Takuya Wada ◽  
Naoya Watabane ◽  
Seijiro Wada ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Single Dose ◽  
Blood Glucose ◽  
Crossover Trial ◽  
Postprandial Blood Glucose ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Glucose Levels ◽  
Blood Glucose Levels

Limited studies have demonstrated that chronic consumption of pinitol improved glucose tolerance, and single-dose ingestion (0.6 g) 60 minutes prior to meals suppressed postprandial glucose levels in patients with type 2 diabetes mellitus. However, higher doses (6 g) were required in healthy people who ingested pinitol with a meal. This randomized, double-blind, placebo-controlled, crossover trial was conducted to clarify the effect of 0.6 g of pinitol with a meal on postprandial blood glucose levels in healthy adults. Twenty volunteers aged 18 to 25 years participated in this study. Participants visited the laboratory after an overnight fast. After measuring fasting blood glucose levels (FBG), they consumed test food (0.6 g of pinitol or placebo) and then ate breakfast (577 kcal; protein 14.0 g; fat 5.6 g; and carbohydrate 117.7 g). Blood glucose levels were measured immediately after eating and at 30, 60, 90, and 120 minutes after breakfast. Participants’ mean FBG level was 102.6 ± 8.2 mg/dL. Participants were categorized by their FBG as normal ( n = 5; ≤99 mg/dL) or impaired glucose tolerance (IGT) ( n = 15; 100-125 mg/dL). The incremental area under the curve of blood glucose over 120 minutes after the meal was significantly suppressed by pinitol in the IGT group ( P < 0.05), but not in the normal group. Therefore, pinitol was considered to maintain postprandial blood glucose levels in healthy people with IGT, and may contribute to the prevention of type 2 diabetes.

Psychomotor performance in healthy young adult volunteers peceiving lormetazepam and placebo: A single-dose, randomized, double-blind, crossover trial

2005 ◽  
Vol 27 (1) ◽  
pp. 78-83 ◽  
Author(s):  
Monica Fabbrini ◽  
Cristina Frittelli ◽  
Enrica Bonanni ◽  
Michelangelo Maestri ◽  
Maria Laura Manca ◽  
...  
Keyword(s):  
Single Dose ◽  
Young Adult ◽  
Psychomotor Performance ◽  
Crossover Trial ◽  
Healthy Young Adult ◽  
Double Blind ◽  
Adult Volunteers

scholarly journals Effect of a Single Dose Montelukast Sodium on Methacholine Chloride PC20

2005 ◽  
Vol 12 (1) ◽  
pp. 26-28 ◽  
Author(s):  
Beth E Davis ◽  
Donald W Cockcroft
Keyword(s):  
Single Dose ◽  
Crossover Trial ◽  
Chloride Concentration ◽  
Forced Expiratory Volume ◽  
Tidal Breathing ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Crossover Trial ◽  
Montelukast Sodium ◽  
Airway Response

BACKGROUND: It is currently recommended that leukotriene modifiers (receptor antagonists and synthesis inhibitors) be withheld for a minimum of 24 h before direct bronchoprovocation testing, but there is little evidence to support this recommendation.OBJECTIVE: To examine the effect of a single oral dose of montelukast sodium 10 mg on airway response to methacholine chloride-induced bronchoconstriction.METHODS: A double-blind, placebo-controlled, randomized crossover trial was performed in 12 subjects with asthma whose methacholine chloride concentration causing a 20% decrease in the forced expiratory volume during the first second of exhalation (PC20) was 8 mg/mL or lower and a baseline forced expiratory volume during the first second of exhalation of 70% predicted or greater. Two-minute tidal breathing methacholine chloride inhalation challenges were performed 1 h and 25 h after both 10 mg montelukast sodium and identical-appearing placebo.RESULTS: There were no significant differences in the methacholine chloride PC20between active treatment and placebo at 1 h post-10 mg montelukast sodium (1.0 mg/mL versus 1.3 mg/mL; n=12; P=0.17, respectively) or at 25 h post-10 mg montelukast sodium (1.4 mg/mL versus 1.9 mg/mL; n=11; P=0.15, respectively).CONCLUSION: A single dose of montelukast sodium did not affect methacholine chloride-induced bronchoconstriction measured after 1 h and 25 h.

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