scholarly journals Platycodi Radix Beverage Reduced the Postprandial Lipemia Response to a High-fat Load in Randomized Controlled Trials of Healthy Subjects (P12-009-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Inhye Lee ◽  
Hansol Lee ◽  
Seunghee Kang ◽  
Soo-yeon Park ◽  
Yeni Lim ◽  
...  
Keyword(s):  
Single Dose ◽  
Lipoprotein Lipase ◽  
Healthy Subjects ◽  
Postprandial Lipemia ◽  
High Fat ◽  
Cooperative Research ◽  
Design Study ◽  
Beverage Consumption ◽  
Platycodi Radix ◽  
Lpl Mass

Abstract Objectives High postprandial lipemia is a characteristic of metabolic abnormality recognized as a risk factor inducing cardiovascular disease. The objective of this study was to investigate the effects of Platycodi radix (PR) beverage on postprandial lipemia response after challenging with a high-fat/sugar load using both single-dose cross-over and 8-week repeated paralleled designs in healthy subjects. Methods A total of 52 and 96 subjects were included in the two studies, respectively. Postprandial blood samples were collected at designated time points from 0 to 6 hours after a high-fat load at each visit to determine triglyceride (TG) and lipoprotein lipase (LPL) activity and mass in plasma, chylomicron and very low-density lipoprotein (VLDL). A general linear mixed-effect model analysis of time point values and area under the curves (AUCs) was performed to estimate the effect of PR beverage on postprandial lipemia response. Results In a single-dose cross-over design study, PR beverage consumption significantly increased lipoprotein lipase mass (P = 0.011, β estimate = 4.295) and reduced TG concentration in VLDL (P = 0.038, β estimate = −52.69) at 6-hour as compared to those in placebo consumption with a high-fat load. Postprandial TG responses as measured by AUC for 6 hours were significantly correlated with a high-fat dietary score MEDFICTS in chylomicron (r = 0.276, P = 0.008) and VLDL (r = 0.213, P = 0.040). In a 8-week repeated parallel design study, postprandial lipemia responses were compared considering the interaction between group and week. PR beverage consumption decreased postprandial serum TG response (AUCn, P = 0.039; total AUC, P = 0.088). In addition, PR increased plasma LPL mass (AUCn, P = 0.076) that is a clearing factor that hydrolyzed TG of chylomicron and VLDL in the lipoprotein metabolism. Conclusions In both of single and long-term intake, PR beverage consumption improved the degradation of postprandial TG level with increasing postprandial LPL mass. However, detail LPL mechanisms of PR consumption should be further analyzed. Funding Sources This work was carried out with the support of “Cooperative Research Program for Agriculture Science & Technology Development” Rural Development Administration, Republic of Korea and the BK21 PLUS program of the Ministry of Education.

Pharmacokinetic evaluation of tapentadol extended-release tablets in healthy subjects

2013 ◽  
Vol 9 (4) ◽  
pp. 291-300 ◽  
Author(s):  
Peter N. Zannikos, PhD ◽  
Johan W. Smit, PhD ◽  
Hans-Jürgen Stahlberg, MD ◽  
Birger Wenge, PhD ◽  
Vera M. Hillewaert, MSc ◽  
...  
Keyword(s):  
Single Dose ◽  
Steady State ◽  
Polyethylene Oxide ◽  
Healthy Subjects ◽  
Extended Release ◽  
The United States ◽  
Repeated Dose ◽  
High Fat ◽  
Japanese Men ◽  
Fat Meal

Objective: To evaluate serum pharmacokinetics of tapentadol administered to healthy subjects as extended-release (ER) tablets.Design: Seven single-dose studies (five randomized, crossover, bioequivalence studies; a study in Japanese men; and a randomized, crossover, effects-of-food study) and one repeated-dose study.Setting: Clinical research settings in the United States and The Netherlands.Patients or participants: Healthy males and females were enrolled into seven studies; one study enrolled only Japanese males.Interventions: In the bioequivalence studies, subjects first received one polyethylene oxide- or hypromellose-based tapentadol ER tablet (50, 100, 150, 200, or 250 mg; one dose per study), then (after washout) the other formulation (matching dose). In all other studies, subjects received polyethylene oxide-based tapentadol ER tablets. In the repeated-dose study, subjects received one 250 mg tablet, then (after washout) one 250 mg tablet every 12 hours (five doses). In the food-effect study, subjects received one 250 mg tablet within 30 minutes after a high-fat meal or after 10 hours of fasting. In the study in Japanese men, subjects received one 100 mg tablet.Main outcome measures: Maximum tapentadol concentrations (Cmax) were typically observed 5 hours after dosing. Mean terminal half-life values ranged from 4.4 to 5.9 hours. Tapentadol Cmax and AUC values increased proportionally following single ER (polyethylene oxide-based tablets) doses of 50 to 250 mg. Trough tapentadol concentrations increased during repeat dosing until reaching steady-state by the third dose. Serum Cmax and area under the concentration-time curve (AUC) values at steady state were 1.6 and 1.9 times higher relative to singledose administration. Coadministration of the 250 mg dose with a high-fat meal increased Cmax and AUC values by an average of 17 percent.Conclusions: The pharmacokinetics of tapentadol ER are consistent after repeated and single-dose administration. Tapentadol ER may be administered without regard to food intake. No clinically significant differences were observed in the pharmacokinetics of tapentadol between Japanese and Caucasian subjects.

scholarly journals Effect of Food on the Pharmacokinetics of the Integrase Inhibitor Dolutegravir

2011 ◽  
Vol 56 (3) ◽  
pp. 1627-1629 ◽  
Author(s):  
Ivy Song ◽  
Julie Borland ◽  
Shuguang Chen ◽  
Parul Patel ◽  
Toshihiro Wajima ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Integrase Inhibitor ◽  
High Fat ◽  
Time Curve ◽  
Clinical Safety ◽  
Fasted State ◽  
Concentration Time ◽  
Rate Of Absorption ◽  
Effect Of Food

ABSTRACTHealthy subjects received dolutegravir at 50 mg in a single-dose crossover study while they were in the fasted state or with low-, moderate-, or high-fat meals. Food increased dolutegravir exposure and reduced the rate of absorption. The area under the concentration-time curve from 0 h to infinity (AUC0–∞) increased by 33%, 41%, and 66% when administered with low-, moderate-, or high-fat meals, respectively, compared with fasting. This increase in dolutegravir exposure is not anticipated to impact clinical safety, and therefore dolutegravir can be taken with or without food and without regard to fat content.

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