None listed
Conditions
Interventions
Intervention1: Brimonidine tartrate ophthalmic suspension: Single drop of brimonidine tartrate ophthalmic suspension in each eye once daily for 7 days.
Control Intervention1: NOT APPLICABLE: NOT APPL
Sponsors
Sun Pharma Advanced Research Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed