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IVIVR Assessing PK Parameters Used to Establish Bioequivalence

NCT02398448 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-01-01

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Ardea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Storgard · Ardea Biosciences, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398448 on ClinicalTrials.gov