Completed PHASE1 INTERVENTIONAL 1-arm 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

Sponsor: Ardea Biosciences, Inc.

Conditions Healthy

Interventions Allopurinol 300 mg; alternative condition 2 Allopurinol 300 mg; alternative condition 3 Allopurinol 300 mg; undergranulated, high hardness condition Zyloprim® 300 mg

Updated 5 times since 2017 Last updated: Dec 31, 2015 Started: Apr 30, 2015 Primary completion: Jul 31, 2015 Completion: Sep 30, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02398448, this PHASE1 trial focuses on Healthy and remains completed. Sponsored by Ardea Biosciences, Inc., it has been updated 5 times since 2015, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Apr 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Ardea Biosciences, Inc.
Quotient Clinical

Data source: Ardea Biosciences, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Ruddington, United Kingdom