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临床试验/CTRI/2019/03/018023
CTRI/2019/03/018023已完成1 期

A Multiple-Dose, Pharmacokinetic and Safety Study of Brimonidine Tartrate Ophthalmic Suspension in Healthy Adult Subjects.

Sun Pharma Advanced Research Company Limited0 个研究点目标入组 13 人开始时间: 待定最近更新:

试验速览

阶段
1 期
状态
已完成
入组人数
13

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Healthy male and female aged 18 to 45 years inclusive having weight at least 50 Kg and having BMI within 18.5 to 29.99 kg per metre square inclusive.
  • 2. Provide signed and dated informed consent in accordance with GCP and local legislation prior to any study procedures and adhere to protocol requirements throughout the study period.
  • 3. Women of childbearing potential must not be pregnant or lactating (as confirmed by a negative pregnancy test).

排除标准

  • 1. Pregnant females or nursing mothers at screening
  • 2. Positive screen on hepatitis B surface antigen, antibodies to the hepatitis C virus or antibodies to the human immunodeficiency virus and Rapid plasma reagin test.
  • 3. Any clinically significant finding on clinical examination or 12 Lead ECG or laboratory investigations during screening.
  • 4. Have any known allergy or sensitivity to the study medications or their components
  • 5. Have a condition or be in a situation which in the investigators opinion, may put the subject at a significant risk, may confound study results, or may interfere significantly with the subjects participation in the study.

研究者

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