J Clin Pharmacol
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PHARMACOKINETICS AND PHARMACODYNAMICS

Pharmacokinetics and Pharmacodynamics of a Novel Nizatidine Controlled-Release Formulation in Healthy Subjects

Robert A. Blum, PharmD, Alan J. Braverman, PharmD, Patricia Rice, MS and Franklin K. Johnson, MS

From Buffalo Clinical Research Center, LLC, Buffalo, New York (Dr. Blum); SCIREX Corporation, Horsham, Pennsylvania (Dr. Braverman, Ms. Rice); and Reliant Pharmaceuticals, LLC, Liberty Corner, New Jersey (Mr. Johnson).

The pharmacokinetics and intragastric pH effects of a novel nizatidine controlled-release (CR) formulation were compared to a currently marketed immediate-release (IR) nizatidine formulation (Axid®). The bimodal pulsatile release characteristics of nizatidine CR decreased its Cmax by approximately 42% compared to nizatidine IR while maintaining 90% relative bioavailability; tmax was approximately 1.6 times longer with the CR formulation. These characteristics enabled controlled-release nizatidine to sustain effective plasma drug concentrations for a greater duration than immediate-release nizatidine over the dosing intervals. In multiple doses, the 24-hour AUC ratio for all comparisons of nizatidine CR 150 mg bid, nizatidine CR 300 mg daily, and nizatidine IR 150 mg bid was between 97% and 99%. Mean pH AUC values for nizatidine CR 150 mg bid and nizatidine IR 150 mg bid were similar overall during the 0- to 14-hour and 14- to 24-hour dosing intervals. For the 14- to 24-hour dosing interval, nizatidine CR 150 mg maintained gastric pH over 3.0 and 4.0 for 42% and 27% of the time compared to 39% and 23% for nizatidine IR, respectively. Nizatidine CR 300 mg, compared to the 150-mg CR and IR regimens, had a greater effect on increasing evening intragastric pH, thus providing support for the potential utility of nizatidine CR 300 mg dosed at night in alleviating nocturnal symptoms of gastroesophageal reflux disease.

Address for reprints: Robert A. Blum, PharmD, Buffalo Clinical Research Center, LLC, 1275 Delaware Avenue, 2nd Floor, Buffalo, NY 14209.


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