To know the amount of the drug and safety of Brimonidine Tartarate ophthalmic suspensio
- Registration Number
- CTRI/2019/03/018023
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method systemic exposure of brimonidine following topical ocular administration of brimonidine tartrate ophthalmic suspension.Timepoint: predose and up to 24 hrs after dose administration on Day1 and Day 7
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI