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

Completed · Not applicable

Conditions studied: Diabetic Gastroparesis

In brief

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.

Key facts

Study ID

NCT00139893

Run by

UCB Pharma

Starts

2005-06-01

Last updated by the study team

2013-03-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Schwarz — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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