A two-way cross-over study to compare the PK of LUC-06 and Carbaglu®.

• Research type

  Research Study

• Full title

  An Open-Label, Two-Way Cross-Over Bioequivalence Study to Compare the Pharmacokinetic Profile of a Single Oral Dose of LUC-06 (test carglumic acid) tablet with a Single Oral Dose of Carbaglu® (reference carglumic acid) tablet

• IRAS ID

  140783

• Contact name

  Olufeyikemi Oluwayi

• Contact email

  Olufeyikemi.Oluwayi@quintiles.com

• Sponsor organisation

  Lucane Pharma

• Eudract number

  2013-003966-15

• ISRCTN Number

  ISRCTN

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/1963

• Date of REC Opinion

  31 Jan 2014

• REC opinion

  Favourable Opinion