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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Metoclopramide

Criteria

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