Phase I Clinical Study, Evaluating Safety and Tolerability of PRO-232 an Ophthalmic Solution, Versus Placebo, When Applied to the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.

This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo.

Start Date30 May 2024

Sponsor / Collaborator

Laboratorios Sophia SA de CV

CTR20230646

/ CompletedPhase 1

OT-601-C在中国健康受试者中单次、多次给药的药代动力学特征和安全性的Ⅰ期临床研究

[Translation] Phase I clinical study on the pharmacokinetic characteristics and safety of single and multiple doses of OT-601-C in healthy Chinese subjects

观察中国健康受试者单次和多次使用OT-601-C的人体药代动力学特征。评价中国健康受试者单次和多次使用OT-601-C的安全性。

[Translation]

To observe the human pharmacokinetic characteristics of OT-601-C after single and multiple administration in healthy Chinese subjects. To evaluate the safety of OT-601-C after single and multiple administration in healthy Chinese subjects.

Start Date17 Mar 2023

Sponsor / Collaborator

Ocumension Suzhou Biotech Co., Ltd.

[+1]

CTR20201037

/ CompletedPhase 3

盐酸环丙沙星氟轻松滴耳液治疗急性外耳道炎的有效性和安全性的Ⅲ期临床研究

[Translation] Phase III clinical study on the efficacy and safety of ciprofloxacin hydrochloride and fluocinolone acetonide ear drops in the treatment of acute otitis externa

主要目的：评估盐酸环丙沙星氟轻松滴耳液对比环丙沙星滴耳液治疗急性外耳道炎的有效性次要目的：评估盐酸环丙沙星氟轻松滴耳液对比环丙沙星滴耳液治疗急性外耳道炎的安全性；测定盐酸环丙沙星氟轻松滴耳液多次给药后在部分成人患者血浆中的环丙沙星及氟轻松的浓度，评价其药代动力参数

[Translation]

Primary objective: To evaluate the effectiveness of ciprofloxacin hydrochloride fluocinolone acne ear drops versus ciprofloxacin ear drops in the treatment of acute external otitis Secondary objective: To evaluate the safety of ciprofloxacin hydrochloride fluocinolone acne ear drops versus ciprofloxacin ear drops in the treatment of acute external otitis; to determine the concentrations of ciprofloxacin and fluocinolone acne in the plasma of some adult patients after multiple administrations of ciprofloxacin hydrochloride fluocinolone acne ear drops, and to evaluate its pharmacokinetic parameters

Start Date04 Jan 2021

Sponsor / Collaborator

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

100 Clinical Results associated with Bacterial DNA gyrase x GR

100 Translational Medicine associated with Bacterial DNA gyrase x GR

0 Patents (Medical) associated with Bacterial DNA gyrase x GR

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