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.

Condition	Intervention
Diabetic gastroparesis	Drug: Reglan ODT

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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, Hb1Ac >10%, and concurrent illness interfering with gastrointestinal motility

Please refer to this study by ClinicalTrials.gov identifier  NCT00139893

Margaret Richardson       margaret.richardson@schwarzbiosciences.com

Wisconsin
      Schwarz, Mequoin,  Wisconsin,  United States; Recruiting

Study chairs or principal investigators

Patricia Witt,  Study Director,  Schwarz Pharma   

Study ID Numbers:  SP850
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139893
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06