Bioequivalence 100mg & 2x50mg Diethylcarbamazine tablets (QBR112879)

• Research type

  Research Study

• Full title

  Bioequivalence Study of a 100-mg Tablet (New Formulation) and Two 50-mg Tablets (Reference Formulation) of Diethylcarbamazine Under Fed Conditions in Healthy Subjects

• IRAS ID

  101923

• Contact name

  Stuart Mair

• Sponsor organisation

  Eisai Ltd

• Eudract number

  2012-000506-29

• ISRCTN Number

  n/a

• Research summary

  The sponsor has developed a new formulation of diethylcarbamazine (DEC) as a 100mg tablet. This study will demonstrate the bioequivalence (equivalent presence of the drug in the blood) of the 100mg DEC tablet against the reference product, 2 x 50mg DEC tablets. Healthy subjects will be dosed on two separate occasions with either the 100mg or 2 x 50mg DEC tablets. Blood samples will be collected from pre-dose to 72 hours post-dose.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/0430

• Date of REC Opinion

  12 Apr 2012

• REC opinion

  Further Information Favourable Opinion