[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial), two-formulation, two-sequence, two-period, crossover bioequivalence study of metformin and glibenclamide tablets in healthy Chinese subjects

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂二甲双胍格列本脲片（规格：500mg/2.5mg）和参比制剂二甲双胍格列本脲片（商品名：Glucovance®；规格：500mg/2.5mg；持证商：Merck SANTE S.A.S）后的药代动力学特征，评价两种制剂在空腹/餐后状态下的生物等效性。次要目的：观察受试制剂二甲双胍格列本脲片和参比制剂二甲双胍格列本脲片（Glucovance®）在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation metformin glibenclamide tablets (specification: 500mg/2.5mg) and the reference preparation metformin glibenclamide tablets (trade name: Glucovance®; specification: 500mg/2.5mg; licensee: Merck SANTE S.A.S) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation metformin glibenclamide tablets and the reference preparation metformin glibenclamide tablets (Glucovance®) in healthy Chinese subjects.

Start Date18 Nov 2023

Sponsor / Collaborator

Tonghua Wantong Pharmaceutical Co. Ltd.

NCT04930744

/ RecruitingPhase 2IIT

A Prospective, Randomized Open-Label Phase II Study of the Safety and Tolerability of Metformin in Combination With Standard Antimicrobial Treatment of Pulmonary Tuberculosis in People With TB and Co-infected With HIV

The METHOD study will examine whether adding metformin to standard antibiotic treatment for tuberculosis (TB) in people with HIV is safe and well tolerated. The study will also test if adding metformin clears the infection more quickly and with less lung damage. When enrolled, participants will have an equal chance of being in the group that takes standard TB medicines alone or in the group that also takes metformin. Participants will have a chance to be put on either: 1) standard TB medicines (isoniazid, rifampicin, ethambutol and pyrazinamide for two months, continuing isoniazid and rifampin for four more months) only; or 2) the same standard TB medicines plus metformin. Participants randomized to the metformin arm will take metformin for eleven weeks, starting one week after starting the standard TB medicines. In addition to monitoring for side effects, all participants will have studies of drug levels and lung and immune function.

Start Date26 Aug 2021

Sponsor / Collaborator

University of Massachusetts

[+4]

CTR20211771

/ CompletedNot Applicable

三门峡赛诺维制药有限公司生产的二甲双胍格列本脲片（Ⅱ）（500 mg/5 mg）与Merk SANTE S.A.S 持证的二甲双胍格列本脲片（商品名：GlucovanceTM，500 mg/5 mg）在健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究

[Translation] A single-dose, randomized, open-label, two-period, double-crossover, fasting and fed bioequivalence study of metformin glibenclamide tablets (II) (500 mg/5 mg) produced by Sanmenxia Sanowei Pharmaceutical Co., Ltd. and metformin glibenclamide tablets (trade name: GlucovanceTM, 500 mg/5 mg) certified by Merk SANTE S.A.S in healthy subjects

主要研究目的：以 Merk SANTE S.A.S 持证的二甲双胍格列本脲片（商品名：GlucovanceTM）为参比制剂，以三门峡赛诺维制药有限公司生产的二甲双胍格列本脲片（Ⅱ）为受试制剂，通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use the certified metformin glibenclamide tablets (trade name: GlucovanceTM) of Merk SANTE S.A.S as the reference preparation and the metformin glibenclamide tablets (II) produced by Sanmenxia Sanowei Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in humans through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date11 Aug 2021

Sponsor / Collaborator

Sanmenxia Sinovi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Glyburide/Metformin Hydrochloride

100 Translational Medicine associated with Glyburide/Metformin Hydrochloride

100 Patents (Medical) associated with Glyburide/Metformin Hydrochloride

Literatures (Medical) associated with Glyburide/Metformin Hydrochloride

01 May 2023·Clinical Pharmacology in Drug Development

Pharmacokinetic and Bioequivalence Studies of 2 Metformin Glibenclamide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

Article

Author: Chen, Lin ; Huang, Jiao ; Huang, Xiaolun ; Li, Xinjing

AbstractThe rational combination of oral antidiabetic agents is more likely to provide better glycemic control than monotherapy. Metformin glibenclamide tablets can be used as second‐line therapy for patients with type 2 diabetes mellitus who cannot successfully control their blood glucose levels by diet and exercise plus metformin or sulfonylureas. The aim of this study was to evaluate the bioequivalence and safety of metformin hydrochloride and glibenclamide tablets (500 mg/5 mg) prepared by 2 different vendors in healthy Chinese subjects under fasting and fed conditions. This is an open‐label, single‐center, randomized, 2‐formulation, 2‐period crossover study. After screening, 40 subjects were enrolled in the fasting trial, while 40 subjects were enrolled in the fed trial. Qualified subjects were randomly assigned to receive a monotherapy dose of 500 mg/5 mg of the test or reference formulation, and after a 1‐week washout period, they took the alternative formulation. Blood samples were collected from 24 blood collection sites per cycle for pharmacokinetic analysis until 36 hours after oral administration. In total, 78 subjects completed the study. Under fasting and fed conditions, the geometric mean ratios of maximum plasma concentration, area under the plasma concentration–time curve (AUC) from time 0 to time of last quantifiable drug level , and AUC from time 0 to infinity between the 2 products, as well as the corresponding 90%CIs, were all within the range of 80%–125%. It was found that exposure (AUC from time 0 to infinity) to metformin is decreased by about 25% in the fed state compared to fasting, whereas glibenclamide exposure is increased by about 30% in the fed state. No severe adverse events were observed in the study.

01 Jan 2019·Acta Endocrinologica (Bucharest)Q4 · MEDICINE

The Effect of Glucovance Therapy on Biomechanical Deterioration of Bone in Streptozotocin-Induced Diabetic Rats

Q4 · MEDICINE

Article

Author: Akarsu, E ; Erdal, N ; Demirel, C ; Yildiz, A ; Korkmaz, H ; Gurgul, S

AIMIs to evaluate the influence of glucovance therapy on biomechanical properties of bone in streptozotocin - induced diabetes mellitus (DM) in rats.MATERIALS AND METHODSA total of 28 male Wistar-Albino rats (12-week-old; 210-300 g) were divided into 4 groups including control (C; no treatment; n=7), sham [Sh; distilled water (gavage, for 8 weeks); n=7], diabetes [DM; streptozotocin (45 mg/kg, single i.p injection); n=7] and diabetes+ Glucovance treatment [DM+G; streptozotocin (45 mg/kg, single i.p injection) + Glucovance (Glucovance, 500/5 mg/kg/day/rat, gavage, for 8 weeks); n=7] groups. Body weight, blood glucose levels (BGLs), bone mineral density (BMD) and geometric/mechanical properties of bone tissue were evaluated. BGLs in diabetic rats were significantly increased compared to non-diabetic rats, while the body weights were decreased (p<0.05).RESULTSA significant difference was not detected between groups with regard to cross-sectional area of diaphyseal femur (p>0.05). Maximum load, energy absorption capacity, ultimate stress, ultimate strain, toughness and displacement were shown to decrease and stiffness was shown to increase in DM rats (p<0.05). Ultimate stress and maximum load were significantly increased in DM+G groups compared to DM groups (p<0.05).CONCLUSIONGlucovance treatment seems to be effective in restoration of biomechanical deterioration of bone specific to STZ-induced DM.

01 Sep 2016·Journal of HypertensionQ2 · MEDICINE

OS 02-06 PHYSIOLOGICAL REGULATION OF VASOMOTION BY INTRACELLULAR ATP-MEDIATED SYSTEM IN HUMAN ARTERY

Q2 · MEDICINE

Article

Author: Kim, Chan Hyung ; Kim, Dae Hoon ; Choi, Woong ; Lee, Sang Eok ; Yun, Hyo-Yung ; Kim, Young Chul ; Lee, Sang Jin

OBJECTIVESpontaneous oscillation of tone of blood vessel called vasomotion cause vessel to flow blood which is an oscillation of flow into an organ. Microcirculation is sensitive to hypoxic condition and metabolism but mechanism of vasomotion is still poorly understood.DESIGN AND METHODPurpose: We studied involvement of metabolism-mediated regulation by intracellular ATP level of vasomotion in human gastric artery.METHODSConventional contractile measuring system and Western blot were used.RESULTSCircular muscle of human gastric artery produced sustained tonic contraction of 1.0 ± 0.19 g by 50 mM high K (n = 36). Pinacidil (10 μM), which is known to activatorof ATP-sensitive K (KATP) channel inhibited vasomotion completely in a reversible manner. Inhibition of vasomotion by activators of KATP channel recovered by glibenclamide. Diazoxide (300 μM), cromakalim (10 μM) nicorandil (10 μM) which is known to activate KATP channel also completely blocked vasomotion in a glibenclamide sensitive manner. Inhibitory effect of these openers of KATP channel on serotonin and norepinephrine-induced contraction were also recoded in a glibenclmide-sensitive manner. In human artery, glucose-free condition which is elated metabolic changes inhibited vasomotion and it was recovered by glibenclamide. Finally, molecular subtypes of KATP channel was defined by Western blot in human artery.CONCLUSIONSVasomotion of human gastroepiploic artery was inhibited by activation of specific subtypes of KATP channel and alteration of metabolism.

100 Deals associated with Glyburide/Metformin Hydrochloride

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	CN	Shanxi Aoxun Medicine Co., Ltd.	01 Jan 2001

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00836472 (CTgov)	Phase 1	-	60	Glyburide/Metformin 5 mg/500 mg Tablets (Glyburide Metformin)	baqsrngpcm(yvtisgtbuj) = bbybraozgu kvsnaijopw (mdwazvyrae, qhxpnxblou - fhekkfzaip) View more	-	04 Aug 2009
				Glucovance® 5 mg/500 mg Tablets (Glucovance®)	baqsrngpcm(yvtisgtbuj) = liswwmvwsd kvsnaijopw (mdwazvyrae, osthowbfdk - kxrtwmwzsr) View more
NCT00835991 (CTgov)	Phase 1	-	60	Glyburide/Metformin 5 mg/500 mg Tablets (Glyburide Metformin)	saewwbveek(ogsiadeayr) = jnzhzyupaq xgfkkjbtqq (ijamnhmjdg, ukileqjxlj - dzffjeogum) View more	-	04 Aug 2009
				Glucovance® 5 mg/500 mg Tablets (Glucovance®)	saewwbveek(ogsiadeayr) = etpopzgaii xgfkkjbtqq (ijamnhmjdg, vkokamsics - otgwwbftcx) View more

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