[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of glipizide controlled-release tablets in healthy subjects under fasting and fed conditions

主要目的：以Pfizer Pharmaceuticals LLC公司生产的格列吡嗪控释片（瑞易宁®，5mg/片）为参比制剂，以天津力生制药股份有限公司生产的格列吡嗪控释片（5mg/片）为受试制剂，通过随机、开放、两制剂、单剂量、双周期、双交叉试验设计，初步比较两制剂的药代动力学特征，并初步评价两制剂在空腹和餐后给药条件下的生物等效性。次要目的：初步评价中国健康受试者单次空腹及餐后口服格列吡嗪控释片受试制剂和参比制剂后的安全性。

[Translation]

Main purpose: Using glipizide controlled-release tablets (Reiyi Ning®, 5 mg/tablet) produced by Pfizer Pharmaceuticals LLC as the reference preparation and glipizide controlled-release tablets (5 mg/tablet) produced by Tianjin Lisheng Pharmaceutical Co., Ltd. as the test preparation, a randomized, open, two-preparation, single-dose, double-period, double-crossover trial design was used to preliminarily compare the pharmacokinetic characteristics of the two preparations and preliminarily evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose: Preliminary evaluation of the safety of the test preparation and reference preparation of glipizide controlled-release tablets after a single fasting and postprandial oral administration in healthy Chinese subjects.

Start Date30 Aug 2024

Sponsor / Collaborator

Tianjin Lisheng Pharmaceutical Co., Ltd.

CTRI/2024/07/071320 / Not yet recruitingNot Applicable

An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose, oral bioequivalence study of Dapagliflozin tablets 10 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500mg (T) Manufactured by Eris Lifesciences Ltd., India with Xigduo® XR 10 mg/ 500 mg (Dapagliflozin 10 mg and Metformin Hydrochloride Extended Release Tablets 500 mg) (R1) Manufactured by AstraZeneca Pharmaceuticals LP, USA and Imported & Marketed by AstraZeneca Pharma India Ltd., Bangalore, India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human male subjects under fasting condition. - NIL

Start Date02 Aug 2024

Sponsor / Collaborator

Eris Lifesciences Ltd.

100 Clinical Results associated with SUR

100 Translational Medicine associated with SUR

0 Patents (Medical) associated with SUR

771

Literatures (Medical) associated with SUR

31 Dec 2024·Channels

Dynamic duo: Kir6 and SUR in K _ATP channel structure and function

Review

Author: ElSheikh, Assmaa ; Zhu, Phillip ; Shyng, Show-Ling ; Patton, Bruce L ; Driggers, Camden M

K_ATP channels are ligand-gated potassium channels that couple cellular energetics with membrane potential to regulate cell activity. Each channel is an eight subunit complex comprising four central pore-forming Kir6 inward rectifier potassium channel subunits surrounded by four regulatory subunits known as the sulfonylurea receptor, SUR, which confer homeostatic metabolic control of K_ATP gating. SUR is an ATP binding cassette (ABC) protein family homolog that lacks membrane transport activity but is essential for K_ATP expression and function. For more than four decades, understanding the structure-function relationship of Kir6 and SUR has remained a central objective of clinical significance. Here, we review progress in correlating the wealth of functional data in the literature with recent K_ATP cryoEM structures.

01 Oct 2024·International Journal of Psychophysiology

Brain and heart activity during interactions with pet dogs: A portable electroencephalogram and heart rate variability study

Article

Author: Thomas, Susan J ; Johnstone, Stuart J ; Teo, Jillian T

Dog ownership has been linked to numerous benefits to human health and wellbeing. However, due to the lack of previous research on changes to brain activity during interactions with pet dogs, the underlying psychophysiological mechanisms are still unclear. The aim of the present study was to examine changes in heart rate (HR), heart rate variability (HRV), and electroencephalogram (EEG) power during interactions between dog owners and their pet dog. Fifty healthy adult dog owners completed baseline psychological measures and pet attachment scales. Subjective units of relaxation (SUR) as well as continuous EEG, HR, and HRV via portable devices were measured during five experimental conditions (baseline resting, relaxation-induction exercise, patting a toy dog, real dog present, and patting a real dog) in participants' homes. SUR was higher in all experimental conditions than at baseline. SUR was also higher during dog interaction than when the dog was present with no interaction. However, SUR during dog interaction was not significantly different from the toy dog and relaxation induction condition. Higher delta, theta, alpha, beta power and HR were found during dog interaction than all other conditions. Higher HRV was found during dog interaction compared to baseline, patting a toy dog, and relaxation-induction exercise, but not significantly different from the real dog present only condition. Lastly, overall HR correlated with psychological measures. Overall, the results show that there are significant changes in brain and heart activity when humans interact with pet dogs, consistent with increases in relaxation and focussed attention. These findings are relevant to understanding the potential mechanisms for health benefits associated with pets.

18 Sep 2024·Function (Oxford, England)

Sulfonylurea receptor pharmacology alters the performance of two central pattern generating circuits in Cancer borealis.

Article

Author: Marder, Eve ; Seddon, Jackie ; Awal, Naziru M ; Kedia, Sonal

Neuronal activity and energy supply must maintain a fine balance for neuronal fitness. Various channels of communication between the two could impact network output in different ways. Sulfonylurea receptors (SURs) are a modification of ATP-binding cassette proteins (ABCs) that confer ATP-dependent gating on their associated ion channels. They are widely expressed and link metabolic states directly to neuronal activity. The role they play varies in different circuits, both enabling bursting and inhibiting activity in pathological conditions. The crab, Cancer borealis, has central patterns generators (CPGs) that fire in rhythmic bursts nearly constantly and it is unknown how energy availability influences these networks. The pyloric network of the stomatogastric ganglion (STG) and cardiac ganglion (GC) control rhythmic contractions of the foregut and heart respectively. Known SUR agonists and antagonists produce opposite effects in the two CPGs. Pyloric rhythm activity completely stops in the presence of a SUR agonist, and activity increases in SUR blockers. This results from a decrease in the excitability of pyloric dilator (PD) neurons, which are a part of the pacemaker kernel. The neurons of the CG, paradoxically, increase firing within bursts in SUR agonists, and bursting slows in SUR antagonists. Analyses of the agonist-affected conductance properties presents biophysical effects that do not trivially match those of mammalian SUR-dependent conductances. We suggest that SUR-associated conductances allow different neurons to respond to energy states in different ways through a common mechanism.

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