A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis
A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis
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.
Inclusion Criteria:

 -  Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis

 Exclusion Criteria:

 -  Serum glucose >300 mg/dL, HbA1C >10%, and concurrent illness interfering with
 gastrointestinal motility