Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139893
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2005-08-29
Brief Title:
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
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
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
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgdL 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
Detailed Description:
See approved Package Insert for Adverse Event information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None