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Journey Medical Corporation公布DFD-29(盐酸米诺环素缓释胶囊,40 mg)与Solodyn®(盐酸米诺环素缓释片,105 mg)的生物利用度研究数据

Journey Medical Corporation Announces Data from Bioavailability Study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg)

GlobeNewswire 等信源发布 2023-10-20 20:30

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Study demonstrated systemic exposure of DFD-29 was significantly lower than that of Solodyn (105 mg) Data presented at 43rd Annual Fall Clinical Dermatology Conference New Drug Application submission to FDA for DFD-29 anticipated in the fourth quarter of 2023 SCOTTSDALE, Ariz., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced data from a comparative bioavailability (bridging) study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs.

研究表明,DFD-29的全身暴露显着低于第43届秋季临床皮肤病学会议上提交的Solodyn(105 mg)数据。预计在2023年第四季度向亚利桑那州斯科茨代尔市提交给FDA的DFD-29新药申请2023年10月20日(GLOBE NEWSWIRE)-旅程医疗公司(纳斯达克股票代码:DERM)(“旅程医疗”),今天,一家主要致力于销售和销售FDA批准的用于治疗皮肤病的处方药的商业阶段制药公司宣布了DFD-29(盐酸米诺环素改性释放胶囊,40)的比较生物利用度(桥接)研究的数据。毫克)vs。

Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg). DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. The data were presented at the 43rd Annual Fall Clinical Dermatology Conference taking place in Las Vegas, NV. “The results of this bioavailability study successfully demonstrate that the systemic exposure of minocycline with DFD-29 (40 mg) was significantly lower than that of Solodyn (105 mg),” said Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical.

Solodyn®(盐酸米诺环素缓释片,105 mg)。DFD-29正在与Reddy博士的实验室有限公司合作开发用于治疗酒渣鼻。数据在内华达州拉斯维加斯举行的第43届秋季临床皮肤病学年会上公布。“这项生物利用度研究的结果成功证明米诺环素与DFD-29(40 mg)的全身暴露显着低于Solodyn(105 mg),”旅行医学研究与开发副总裁Srinivas Sidgiddi说。

“We’re also encouraged by DFD-29’s safety profile demonstrated throughout our ongoing development program.” The single-center, randomized, open-label, laboratory-blinded, three-way, six-sequence crossover study enrolled 24 healthy subjects with three objectives: 1) to assess the comparative bioavailability of DFD-29 vs.

“我们也对DFD-29在我们正在进行的开发计划中展示的安全性感到鼓舞。”单中心,随机,开放标签,实验室盲法,三向,六序列交叉研究招募了24名健康受试者,其目标有三个:1)评估DFD-29与。

Solodyn (105 mg), 2) to evaluate the impact of food on DFD-29 bioavailability and 3) to evaluate the safety and tolerability profile of DFD-29. The mean age of the subjects was 42.4 years, 87%.

Solodyn(105 mg),2)评估食品对DFD-29生物利用度的影响,3)评估DFD-29的安全性和耐受性。受试者的平均年龄为42.4岁,87%。