IVIVR assessing PK parameters used to establish Bioequivalence(116986)

• Research type

  Research Study

• Full title

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

• IRAS ID

  170982

• Contact name

  Chris Storgard

• Sponsor organisation

  Ardea Biosciences, Inc.

• Eudract number

  2014-005463-32

• Clinicaltrials.gov Identifier

  NCT02398448

• Duration of Study in the UK

  0 years, 2 months, 10 days

• Research summary

  The Sponsor is developing the study drug, Allopurinol, for the potential treatment of gout and hyperuricaemia (excessively high levels of Uric acid in the blood).

  The study will try to determine if changes in the formulation of the study drug will have a notable effect on the metabolism of the study drug and quantity of active ingredient available in the body.

  The study will consist of 4 study regimens (A, B, C ,D) involving up to 22 Caucasian male subjects.

  •Regimen A; Allopurinol 300mg, US marketed drug (reference product) (Zyloprim®);

  •Regimen B; Allopurinol 300mg, undergranulated, high hardness condition (Test Product)

  •Regimen C; Allopurinol 300mg, alternative condition 2 (Test Product)

  •Regimen D; Allopurinol 300mg, alternative condition 3 (Test Product)

  The alternative conditions will be variables in the manufacturing process.

  Between each study visit (study visits 1 and 2, 2 and 3, 3 and 4) there will be a break of at least 14 days between dose days both for the study drug to work its way out of the subjects system and for the data produced from the samples to be reviewed. During this review the alternative condition for the next dose will be decided.

• REC name

  HSC REC A

• REC reference

  15/NI/0026

• Date of REC Opinion

  19 Mar 2015

• REC opinion

  Further Information Favourable Opinion