NCT02398448 - IVIVR Assessing PK Parameters Used to Establish Bioequivalence | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

July 31, 2015

Study Completion Date

September 30, 2015

Conditions

Healthy

Interventions

DRUG

Zyloprim® 300 mg

DRUG

Allopurinol 300 mg; undergranulated, high hardness condition

There will be a period for interim analysis after administration of Regimen B to determine the formulation within the process design space that provides the desired in vitro dissolution variant for dosing in the subsequent study period

DRUG

Allopurinol 300 mg; alternative condition 2

There will be a period for interim analysis after administration of Regimen C to determine the formulation within the process design space that provides the desired in vitro dissolution variant for dosing in the subsequent study period

DRUG

Allopurinol 300 mg; alternative condition 3

Trial Locations (1)

NG11 6JS

Ruddington