Phase 1
Completed N=24
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Heartburn
Source: ClinicalTrials.gov NCT00944671 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water — 261.2; 248.0 ng*hr/mL
Summary
A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water |
261.2; 248.0 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water |
45.5; 44.4 | — |
| SECONDARY Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water |
260.1; 248.0 | — |
| SECONDARY Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water |
45.9; 44.4 | — |
Eligibility Criteria
Inclusion Criteria
- Female subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study
- Subject is in good health
- Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day
Exclusion Criteria
- Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery
- Subject has a history of asthma or severe allergies to drugs or foods
- Subject currently uses prescribed or nonprescribed drugs on a regular basis
- Subject has a recent history of drug/alcohol abuse
- Subject consumes more than 6 cups of coffee per day
- Subject has unconventional or extreme dietary habits
- Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
- Subject has a history of allergy or intolerance to antacids
- Female subject is known to be pregnant or is not using reliable means of contraception
Data sourced from ClinicalTrials.gov (NCT00944671). 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.