Bioequivalence study comparing combinations of Memantine and Donepezil

• Research type

  Research Study

• Full title

  A single dose, open label, two way crossover bioequivalence study, comparing combination tablets of 20 mg memantine and 10 mg donepezil (test) with combined dosing of 20 mg memantine tablets and 10 mg donepezil tablets (reference)

• IRAS ID

  59103

• Contact name

  Ashley Brooks

• Contact email

  tom.morley@covance.com

• Sponsor organisation

  Covance Clinical Research Unit

• Eudract number

  2010-018549-73

• Research summary

  Memantine and donepezil are two drugs used in the treatment of Alzheimer's disease (AD). Memantine (licensed 2002) is an NMDA receptor antagonist indicated for the symptomatic treatment of moderate to severe AD. Donepezil (licensed 1997) is an acetylcholinesterase inhibitor indicated for the symptomatic treatment of mild to moderately severe AD.In clinical practice the two drugs are frequently administered in combination so this trial is intended to compare a new combined dose formulation with separate tablets of the marketed drugs.The trial will assess how the levels of the drug in the blood compare between the two methods of administration. The trial will also assess the absorption, breakdown and excretion characteristics of the two formulations, as well as the safety and tolerability characteristics.A total of 24 subjects will be enrolled in this trial and will dosed with the following treatments in consecutive treatment periods:?½ A (test): Combination tablet of 20 mg memantine HCL/10 mg donepezil 10 HCL?½ B (reference): One tablet of 20 mg memantine HCL and one tablet of 10 mg donepezil HCL.12 subjects will receive treatment A then B, and 12 subjects will receive treatment B then A.Subjects will receive either A or B on Day 1 of treatment, remain in the clinic until Day 10, and can then choose to remain resident until Day 14 or return for outpatient visits on Days 12 and 14. Subjects will be dosed with the alternate treatment (either A or B) on Day 22. There will therefore be a washout period of 21 days between dosing. Subjects will remain in the clinic until Day 31, and can then choose to remain in the unit until Day 35 or return for outpatient visits on Days 33 and 35.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/15

• Date of REC Opinion

  5 Aug 2010

• REC opinion

  Favourable Opinion