A multicenter, randomized, open label, two treatment, two period, single-dose, crossover, bioequivalence study of Azacitidine Tablets 300 mg manufactured by Teva, Czech Industries s.r.o. with ONUREG (Azacitidine) Tablets 300 mg manufactured by Celgene Distribution B.V., Netherlands under fasting condition in patients with a confirmed diagnosis of Acute Myeloid Leukemia in remission phase. - NIL

开始日期2024-04-15

申办/合作机构

PLIVA Croatia Ltd.

CTR20233083

/ Active, not recruiting临床1期

一项评估 TV-44749（奥氮平缓释注射用混悬液）在中国精神分裂症患者中的安全性、耐受性和药代动力学的 I 期、单剂量、平行队列研究

评估皮下注射用奥氮平缓释混悬液 (TV-44749) 单次给药用于中国精神分裂症患者的安全性, 耐受性及药代动力学。

开始日期2024-03-28

申办/合作机构

Teva Branded Pharmaceutical Products R&D, Inc.

[+2]

CTR20232834

/ Terminated临床3期

一项评价 TV-44749 治疗精神分裂症成人患者的有效性和安全性的随机、双盲、安慰剂对照研究，包括一个开放标签、长期安全性阶段

:精神分裂症是一种使人衰弱的重度精神病性障碍，其特征包括阳性和阴性症状，全球终生发病风险约为 1%。对于大多数患者来说，这一疾病伴有需要长期使用抗精神病药物治疗的慢性病程。不依从和不遵守长期口服药物治疗方案是精神分裂症和相关疾病治疗中最重要的治疗问题，导致这些患者中的许多频繁复发或加重，且无法从抗精神病药物治疗中完全获益。缓释注射用抗精神病药物可能会提高精神分裂症患者的依从性。目前，奥氮平的口服、长效肌肉注射 (im) 和速效 im 制剂被批准用于治疗患有精神分裂症的成人。一种用于皮下注射 (sc) 的奥氮平缓释混悬液新制剂 (TV-44749) 旨在用于治疗精神分裂症。

开始日期2023-12-22

申办/合作机构

梯瓦医药信息咨询（上海）有限公司

[+2]

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项与 PLIVA Croatia Ltd. 相关的文献（医药）

2025-06-01·European Journal of Pharmaceutical Sciences

Overcoming barriers in formulating practically insoluble loteprednol etabonate in ophthalmic nanoemulsion

Article

作者: Krtalić, Iva ; Petriček, Igor ; Ljubica, Josip ; Pepić, Ivan ; Hafner, Anita ; Bočkor, Luka ; Kučuk, Maša Sufundžić ; Lovrić, Jasmina ; Kocbek, Petra ; Juretić, Marina ; Dukovski, Bisera Jurišić ; Špoljarić, Drago

Loteprednol etabonate (LE) is a soft corticosteroid recently approved for the short-term treatment of signs and symptoms of dry eye disease. LE is available on the market as a suspension, which can release only limited amount of dissolved corticosteroid after application at the ocular surface. This study is focused on the development of an oil-in-water nanoemulsion (NE) to effectively deliver dissolved LE to the ocular surface, in order to promote its absorption. We newly developed an extended-throughput 3D model of the corneal epithelium for biocompatibility study, and an innovative approach to investigate the effect of biorelevant dilution on LE release from the NE oil phase. Castor oil, Capryol® 90, Kolliphor® EL and Soluplus® were selected as NE excipients based on their potential to dissolve LE. Design of experiments was successfully employed to develop biocompatible and physically stable NE with high LE content (0.15 %, w/w) and retention efficiency (87 % after 10 months of storage at room temperature). LE retention within oil droplets (above 90 % of the initial LE content) despite biorelevant dilution simulating tear turnover suggests the potential for direct LE absorption from the NE oil droplets into the lipophilic corneal epithelium. The results obtained encourage the extension of the studies in terms of in vitro permeability and in vivo eye-related bioavailability assessment to prove the potential of the proposed LE formulation.

2025-05-01·Regulatory Toxicology and Pharmacology

A review of the genotoxic effects of antiparasitic drugs on parasites and their hosts

Review

作者: Sjakste, Nikolajs ; Dinter, Domagoj ; Gajski, Goran

Antiparasitic medications are drugs used to treat infections caused by parasites like protozoa, helminths, and ectoparasites by either killing the parasite or inhibiting its growth and reproduction. These medications are crucial for treating parasitic diseases and can vary in dosage and administration depending on the type of infection with proper diagnosis being essential for effective treatment. Nevertheless, such drugs can also cause a range of side effects including genotoxicity, depending on the type of medication and the individual's response. Therefore, here we will summarize data on the genotoxic effects of some antiparasitic drugs since many parasites provoke DNA damage per se, and therapy can enhance such genotoxic effects. The DNA-damaging effects of antiparasitic drugs enable the use of some of them for cancer treatment. Since a parasitic disease comes with severe consequences, the cost-benefit should be considered when taking drugs against such a disease even in terms of their potential genotoxicity. While some antiparasitic drugs have shown genotoxic potential in laboratory studies, most are considered safe for human use at therapeutic doses. Long-term or high-dose exposure may carry more risk; moreover, the genotoxic effects of the drugs can interfere with the genotoxicity of the parasitic infection. More research is needed to fully understand the implications for human health. Nevertheless, the present study has confirmed the need for further cytogenetic research and regular patient monitoring to minimize the risk of an adverse event, especially among frequent travellers visiting parasite-affected areas.

2024-04-01·International Journal of Pharmaceutics

Synergism of polysaccharide polymers in antihistamine eye drops: Influence on physicochemical properties and in vivo efficacy

Article

作者: Krajišnik, Danina ; Stepanović-Petrović, Radica ; Vučen, Sonja ; Pecikoza, Uroš ; Jurišić Dukovski, Bisera ; Račić, Anđelka ; Lovrić, Jasmina ; Bajac, Jelena ; Tomić, Maja ; Micov, Ana ; Dobričić, Vladimir

The incorporation of polymers into drug delivery vehicles has been shown to be a useful approach to prolong the residence time of drugs in the precorneal tear film and to improve penetration into biological membranes. The main objective of this research was to formulate novel viscous eye drops with ketotifen as the active ingredient, containing the polysaccharides: chitosan (MCH), hydroxypropyl guar gum (HPG) and hyaluronic acid (SH) alone and in combination as functional polymers. DSC and FT-IR techniques showed the compatibility between ketotifen and polymers. Physicochemical and rheological analysis at ambient and simulated physiological conditions, as well as the evaluation of mucoadhesive properties showed that vehicles containing combinations of polymers have suitable physicochemical and functional properties with demonstrated synergism between combined polymers (MCH and HPG i.e. SH and HPG). The drug permeability was successfully estimated in vitro using HCE-T cell-based models. MTT cytotoxicity assay demonstrates that the tested formulations were non-toxic and well tolerated. In vivo preclinical study on mice revealed that both vehicles containing mixed polymers enhanced and prolonged the antipruritic/analgesic-like effect of ophthalmic ketotifen. Based on these results, both combinations of polysaccharide polymers, especially SH-HPG, could be considered as potential new carriers for ketotifen for ophthalmic use.

100 项与 PLIVA Croatia Ltd. 相关的药物交易

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100 项与 PLIVA Croatia Ltd. 相关的转化医学

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