Pharmacology study of brimonidine
Phase 1
- Registration Number
- CTRI/2016/01/006491
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Willingness and availability of subject to give written informed consent and adhere to protocol requirements throughout the study period. -Subjects between 18- 45 years male/female of age
IOP not more than 21 mmHg in both the eyes.
-Subjects whose screening laboratory values are within normal limits or considered by the Investigator/sub-Investigator to be of no clinical significance
Exclusion Criteria
-History of allergic hypersensitivity or poor tolerance to any of the components of the preparations used in this study
-Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy
-Progressive retinal or optic nerve disease
-History of chronic or recurrent severe inflammatory eye disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters:Cmax, AUC0-t, AUC0-t, AUC0-t /AUC0-inf, Tmax, t½, Kel; <br/ ><br>Pharmacodynamic paramters: IOP measurement <br/ ><br>Timepoint: Pharmacokinetic parameters:at 0.25, 0.50, 1.00, 2.00, 3.00, 5.00, 8.00, 9.00, 10.00, 11.00, 13.00, 16.00, 17.00, 18.00, 19.00, 21.00 and 24.00 hours after first dosing on Day 01 and 07. <br/ ><br> <br/ ><br>Pharmacodynamic: IOP measurement shall be conducted within 15 minutes prior to dosing [0.00hrs (pre dose) and 24.00 hrs (post dose)] and at 2.00 (±15 min), 8.00 (±15 min), 12.00 (±15 min) hrs post dose on Day 01, 03, 05 and 07 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil