Phase 1
Completed N=30
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
Heartburn
Source: ClinicalTrials.gov NCT00945750 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water — 398.5; 394.8 ng/mL hr
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water |
398.5; 394.8 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water |
67.2; 65.1 | — |
| SECONDARY AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water |
440.1; 394.8 | — |
| SECONDARY Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water |
73.0; 65.1 | — |
Eligibility Criteria
Inclusion Criteria
- Female participant is not pregnant or lactating
- Female of childbearing potential must use reliable means of contraception during the course of the study
- Is in good health
- Is able to abstain from smoking during the 24-hour periods before and during each treatment day
Exclusion Criteria
- Has any major systemic disorders
- Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery
- Has or has a history of any illness or condition that might interfere with optimal participation in the study
- Has a history of asthma or severe allergies to drugs or foods
- Currently uses prescribed or non-prescribed drugs on a regular basis
- Has a recent history of drug/alcohol abuse
- Consumes more than 6 cups of coffee per day
- Has unconventional or extreme dietary habits
- Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
- Has a history of allergy or intolerance to antacids
- Is known to be pregnant or is not using reliable means of contraception
Data sourced from ClinicalTrials.gov (NCT00945750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.