NCT02398448

IVIVR Assessing PK Parameters Used to Establish Bioequivalence

In Vitro-In Vivo Relationship Study to Assess the Impact of the In Vitro Dissolution Profile on the Pharmacokinetic Parameters Used to Establish Bioequivalence

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether defined and limited changes in in vitro dissolution impact the in vivo pharmacokinetics (PK) and relative bioavailability of allopurinol and the active metabolite oxypurinol.

Detailed description

In this study, a single oral dose of Zyloprim® (300 mg tablet) and 3 separate single oral doses of 300 mg allopurinol test formulations (Regimens B, C and D) will be administered sequentially to each subject on separate occasions. Following the administration of Regimens B and C, there will be a period of interim analysis during which the PK data will be reviewed to determine the formulation within the process design space that provides the desired in vitro dissolution variant for dosing in the subsequent study period.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2015-03-25
• Last updated: 2016-01-01

Locations

1 site across 1 country: United Kingdom