At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Famotidine FCT +1 moredrug
Likely dose
Famotidine FCT 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Famotidine FCT and Famotidine CT for Heartburn. Completed, enrolled 30 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeartburn
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
Primary CompletionSep 2006
First PostedJul 2009
TodayJul 2026
First PostedJul 24, 2009
Enrollment StartAug 1, 2006
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago
Interventions
Famotidine FCTdrug
Famotidine 20 mg oral film-coated tablet taken once daily
Famotidine CTdrug
Famotidine 20 mg oral chewable tablet taken once daily