A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets
Summary
This study will determine whether the chewable tablet (CT) formulation of famotidine taken with and without water is bioequivalent to the film coated tablet (FCT) formulation.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Heartburn
Intervention
famotidine film-coated tablet (FCT), Comparator: famotidine chewable tablet (CT), Comparator: famotidine chewable tablet (CT)
Status
Completed
Source
Merck
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00945750
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Famotidine
A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.
X-ray Film
A film base coated with an emulsion designed for use with x-rays.
Dietary Supplements
Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)
Talc
Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)
Polyethylene Glycols
Polymers of ETHYLENE OXIDE and water and their ethers. They vary in consistency from liquid to solid, depending on the molecular weight, indicated by a number following the name. They are used as SURFACTANTS, dispersing agents, solvents, ointment and suppository bases, vehicles, and tablet excipients. Some specific groups are lauromagrogols, nonoxynols, octoxynols and poloxamers.
Clinical Trials
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.
A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fed Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP 20...
A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP 20...
Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famot...
Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
PubMed Articles
The preventive effects of lansoprazole and famotidine on low-dose aspirin-induced gastric mucosal injury in relation to gastric acidity were compared in healthy Japanese volunteers. Fifteen Helicobact...
Liquid chromatography with electrospray ionization mass spectrometry for the quantitative determination of famotidine in human urine, maternal and umbilical cord plasma was developed and validated. Th...
Preparation and Evaluation of Famotidine Polymorphs.
The main objective of this study was to compare the behaviour of drug release among the famotidine polymorphs prepared by using various additives and solvents, by solvent evaporation method. The famot...
BACKGROUND: A therapeutic strategy for symptomatic patients with chronic gastritis has not been established. Gastric acid has been reported to induce a variety of unpleasant abdo...
PURPOSE: This randomized, double-blind, controlled study examined whether lafutidine is superior to placebo and non-inferior to famotidine in terms of healing rates as assessed by endoscopy in Japanes...
