Bioequivalence of naproxcinod 750mg manufactured in 2 different sites

• Research type

  Research Study

• Full title

  Comparison of the Pharmacokinetics of Naproxen after oral administration of a single dose of Naproxcinod 750 mg using naproxcinod 375 mg capsules manufactured in either Capsugel Colmar (FR) or Capsugel Ploermel (FR). A Bioequivalence, Phase 1, Single-Center, Randomized, Open Label, Two-Period, Two-Sequence Single Dose Cross-Over Study in Male Healthy Subjects.

• IRAS ID

  62583

• Contact name

  Stuart J Mair

• Sponsor organisation

  NicOx S.A.

• Eudract number

  2010-022379-74

• Research summary

  Comparison of the Pharmacokinetics of naproxen following oral administration of a single dose of naproxcinod 750 mg which has been manufactured at two different sites, to demonstrate bioequivalence.Twenty six male subjects will be randomised to take two capsules manufactured at one site in the first study period and two capsules manufactured at the second site in the second study period in order to show there is no variation between the capsules manufactured by Capsugel at different sites and the body's action on the drug. Each period will last 72 hours with a period of 7 days between the two study dosing occasions. This is to allow the first formulation of naproxcinod to be removed completely from the body before the second administration is given.This study is required to support an application to market a formulation of naproxcinod.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/27

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Further Information Favourable Opinion