Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-26 @ 6:26 PM
Study NCT ID:
NCT00945750
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009_621 | OTHER | Merck Registration Number | View |