J Clin Pharmacol
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DRUG INTERACTIONS

Steady-State Pharmacokinetics of Galantamine Are Not Affected by Addition of Memantine in Healthy Subjects

Caiping Yao, PhD, Arash Raoufinia, PharmD, Michael Gold, MD, Jeffrey S. Nye, MD, PhD, Steven Ramael, MD, Mukund Padmanabhan, MS, Yolande Walschap, LicBiol, Tom Verhaeghe, PhD and Qinying Zhao, PhD

From Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, New Jersey (Dr Yao, Dr Raoufinia, Dr Gold, Dr Nye, Dr Zhao); SGS Biopharma S.A. Research Unit Stuivenberg, Antwerp, Belgium (Dr Ramael); Smith Hanley Consulting Group, Lake Mary, Florida (Mr Padmanabhan); Johnson & Johnson Pharmaceutical Research & Development, LLC, Beerse, Belgium (Dr Verhaeghe, Dr Walschap). Drs Yao, Gold, and Zhao are members of the American College of Clinical Pharmacology.

To evaluate the effect of multiple doses of memantine on the pharmacokinetics of galantamine and to assess the safety and tolerability of galantamine with adjunctive memantine treatment, an open-label, single-center, drug interaction study was conducted in 16 healthy adults. Subjects received an 8-mg dose of galantamine extended release once daily during week 1 and a 16-mg dose of galantamine extended release once daily during week 2. During weeks 3 and 4, they received a 16-mg dose of galantamine extended release once daily and a 10-mg dose of memantine twice daily, except on days 1 and 2 of week 3, when memantine was given as 10 mg once daily. The pharmacokinetic profile and parameters of galantamine at steady state were similar after administration of a 16-mg dose of galantamine once daily alone and after administration with a 10-mg dose of memantine twice daily. Galantamine 16 mg once daily with adjunctive memantine 10 mg twice daily was well tolerated and safe in healthy subjects.

Key Words: Alzheimer's disease • galantamine • memantine • drug interaction • pharmacokinetics

Address for reprints: Qinying Zhao, PhD, Johnson & Johnson Pharmaceutical Research & Development, LLC, 1125 Trenton-Harbourton Road, PO Box 200, Titusville, NJ 08560.


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G. T. Grossberg, K. R. Edwards, and Q. Zhao
Rationale for Combination Therapy With Galantamine and Memantine in Alzheimer's Disease
J. Clin. Pharmacol., July 1, 2006; 46(suppl_1): 17S - 26S.
[Abstract] [Full Text] [PDF]


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