Pharmacology study of brimonidine

A RANDOMIZED, OPEN LABEL, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, MULTIPLE DOSE, CROSSOVER, COMPARATIVE PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF BRIMONIDINE TARTRATE OPHTHALMIC SUSPENSION 0.35% (OD ADMINISTRATION) OF SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED, INDIA, AND ALPHAGANÂ® P (BRIMONIDINE TARTRATE) OPHTHALMIC SOLUTION 0.1% (TID ADMINISTRATION) OF ALLERGAN, INC., IN 40 HEALTHY HUMAN ADULT SUBJECTS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/01/006491

Enrollment

Registered

2016-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Brimonidine Tartrate Ophthalmic Suspension 0.35% of Sun Pharma Advanced Research Company Limited: Brimonidine Tartrate Ophthalmic Solution (0.35%) dose frequency: once a day for 7 days

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters:Cmax, AUC0-t, AUC0-t, AUC0-t /AUC0-inf, Tmax, tÂ½, Kel; Pharmacodynamic paramters: IOP measurement 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. 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 (Â±15 min), 8.00 (Â±15 min), 12.00 (Â±15 min) hrs post dose on Day 01, 03, 05 and 07	—

Measure

Time frame

Pharmacokinetic parameters:Cmax, AUC0-t, AUC0-t, AUC0-t /AUC0-inf, Tmax, tÂ½, Kel; Pharmacodynamic paramters: IOP measurement 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. 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 (Â±15 min), 8.00 (Â±15 min), 12.00 (Â±15 min) hrs post dose on Day 01, 03, 05 and 07

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Ltd.

clinical.trials@sparcmail.com91-22-66455645

Outcome results