A Single-centre, Parallel-cohort, Open-label Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of the HR20033in Healthy Chinese Subjects

According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group.
The primary objective is to (1) assess the effect of a meal (light-fat) on the single-dose PK of SHR3824 and metformin administered in the HR20033 FDC tablet in healthy Chinese subjects; (2) to characterize the single-dose and steady-state PK of SHR3824 and metformin following administration of the HR20033 FDC tablet to healthy subjects in the fed state.
The secondary objective is to assess in healthy Chinese subjects, the safety and tolerability of the SHR3824 and Metformin after single doses (administered in the fed and fasted states) and multiple doses (administered in the fed state) of the HR20033 FDC tablet.

Start Date13 Oct 2021

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.Startup

NCT00967811 / CompletedPhase 2

An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.

Start Date01 Aug 2009

Sponsor / Collaborator

Mati Therapeutics, Inc.

100 Clinical Results associated with Latanoprost/Phentolamine

100 Translational Medicine associated with Latanoprost/Phentolamine

100 Patents (Medical) associated with Latanoprost/Phentolamine

307

Literatures (Medical) associated with Latanoprost/Phentolamine

01 Oct 2024·Journal of Hypertension

Use of fixed-dose combinations for cardiovascular indications from 2018 to 2023: a nationwide population-based study

Article

Author: Lauder, Lucas ; Kunz, Michael ; Mahfoud, Felix ; Schulz, Martin ; Laufs, Ulrich ; Daudí, Andrea Espinosa ; Götzinger, Felix ; Böhm, Michael ; Kieble, Marita

Aims:Clinical guidelines support the use of fixed-dose combinations (FDC) for prevention of cardiovascular disease. Implementation of FDC into clinical care remains challenging, and current population-based data are scarce.Methods and results:Claims data on dispensed drugs in an outpatient care setting of approximately 87% of the German population were analysed regarding the use of FDC according to time, age of the insured persons, and active ingredients. The overarching trend for all FDC revealed a decrease from 77.3 defined daily doses per 1000 statutory health-insured (SHI) persons per day (DID) in the second half-year of 2018 (2018HY02) to 60.8 DID in the first half-year of 2023 (2023HY01) (Spearman ρ = -0.988; P < 0.001). The total DID for all antihypertensives (AHT) increased from 590.6 in 2018HY02 to 624.8 in 2023HY01 (ρ = 0.855; P = 0.002), but the DID for fixed-dose AHT (AHT-FDC) declined from 74.1 in 2018HY02 to 55.0 in 2023HY01 (ρ = -0.988; P < 0.001). Conversely, the use of all lipid-lowering agents (LLA) and LLA-FDC continuously increased: The total DID of all LLA rose from 92.5 in 2018HY02 to 134.4 in 2023HY01 (ρ = 1.000; P = 0.000), and for LLA-FDC from 3.1 in 2018HY02 to 5.5 DID in 2023HY01 (ρ = 0.915; P < 0.001). AHT-FDC and LLA-FDC were less frequently dispensed to patients at least 80 years than to patients less than 80 years. Dispensing of multiple purpose FDC increased from 2018HY02 to 2023HY01 from 0.11 DID to 0.26 DID (ρ = 1.000; P = 0.000) but remained negligible.Conclusion:Use of AHT-FDC in Germany is declining. In contrast, FDC containing LLA are increasingly prescribed. Dispensing of multiple purpose FDC is very low. Strategies are needed to facilitate the use of FDC as recommended by current guidelines.

07 Aug 2024·Antimicrobial Agents and Chemotherapy

Cefiderocol heteroresistance associated with mutations in TonB-dependent receptor genes in Pseudomonas aeruginosa of clinical origin

Article

Author: Arias, Cesar A ; Dinh, An Q ; Alcalde, Manuel ; Rizvi, Samie A ; Tran, Truc T ; Hakki, Morgan ; Baptista, Rodrigo P ; Miller, William R ; Egge, Stephanie L ; Martinez, Jose R W ; Munita, Jose M ; Shelburne, Samuel A ; Simar, Shelby R ; Hanson, Blake M

ABSTRACT The siderophore-cephalosporin cefiderocol (FDC) presents a promising treatment option for carbapenem-resistant (CR) P. aeruginosa (PA). FDC circumvents traditional porin and efflux-mediated resistance by utilizing TonB-dependent receptors (TBDRs) to access the periplasmic space. Emerging FDC resistance has been associated with loss of function mutations within TBDR genes or the regulatory genes controlling TBDR expression. Further, difficulties with antimicrobial susceptibility testing (AST) and unexpected negative clinical treatment outcomes have prompted concerns for heteroresistance, where a single lineage isolate contains resistant subpopulations not detectable by standard AST. This study aimed to evaluate the prevalence of TBDR mutations among clinical isolates of P. aeruginosa and the phenotypic effect on FDC susceptibility and heteroresistance. We evaluated the sequence of pirR , pirS , pirA , piuA , or piuD from 498 unique isolates collected before the introduction of FDC from four clinical sites in Portland, OR (1), Houston, TX (2), and Santiago, Chile (1). At some clinical sites, TBDR mutations were seen in up to 25% of isolates, and insertion, deletion, or frameshift mutations were predicted to impair protein function were seen in 3% of all isolates ( n = 15). Using population analysis profile testing, we found that P. aeruginosa with major TBDR mutations were enriched for a heteroresistant phenotype and undergo a shift in the susceptibility distribution of the population as compared to susceptible strains with wild-type TBDR genes. Our results indicate that mutations in TBDR genes predate the clinical introduction of FDC, and these mutations may predispose to the emergence of FDC resistance.

01 Aug 2024·Transplant Infectious Disease

Cefiderocol utilization in lung transplant recipients at a single center

Article

Author: Budev, Marie ; Xhemali, Xhilda ; Neuhaus, Kristen ; Lum, Jessica ; Persaud, Purnadeo N

AbstractBackgroundMultidrug‐resistant organisms are increasing and are a significant cause of mortality among lung transplant recipients (LTRs). To assist with this issue, novel pharmacotherapies are being developed. This study describes the utilization of a novel antibiotic, cefiderocol (FDC), in LTRs where limited data exists in the current literature. We primarily assessed the clinical indications, duration of therapy, resistance, and adverse effects.MethodsConducted as a single‐center retrospective review, this study included adult LTRs who received FDC for at least 24 h. Data, extracted from electronic medical records, encompassed patient demographics, transplant history, antimicrobial dosing, adverse effects, bacterial cultures, and outcomes. The research protocol received institutional review board approval.ResultsFDC exhibited effectiveness against multidrug‐resistant Pseudomonas aeruginosa, with 26% 30‐day mortality and microbiological clearance observed in nine out of 13 cases. Notably, FDC was used in diverse clinical settings, including for prophylaxis, empiric, and targeted treatment.ConclusionFurther studies are needed to evaluate optimal clinical indications for FDC use in LTRs.

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100 Deals associated with Latanoprost/Phentolamine

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Indication	Highest Phase	Country/Location	Organization	Date
Mydriasis	NDA/BLA	US	Opus Genetics, Inc.	06 Dec 2022
Glaucoma	Preclinical	US	Opus Genetics, Inc.	15 Aug 2019

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