To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is
metabolized faster than the conventional Reglan tablet in patients with diabetic
gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being
compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented
gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each
dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent
illness interfering with gastrointestinal motility. Subjects will stay in the clinic
overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning
dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve
(AUC) from time zero to 8 hr will be compared for the 2 formulations.
See approved Package Insert for Adverse Event information.
- Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis
- Serum glucose >300 mg/dL, HbA1C >10%, and concurrent illness interfering with