Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions
Summary
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Bioavailability
Intervention
Famotidine Tablets, 40 mg
Status
Completed
Source
Perrigo Company
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00802828
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Famotidine
A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.
Indinavir
A potent and specific HIV protease inhibitor that appears to have good oral bioavailability.
Lactose
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
Tablets
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Clinical Trials
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...
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets
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.
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
Famotidine is generally employed for the treatment of gastric ulcer. The present study was conducted to fabricate famotidine tablets using various diluents. The binder was incorporated to the formulat...
Aim:To develop a novel gastroretentive drug delivery system based on a self-microemulsifying (SME) lipid mixture for improving the oral absorption of the immunosuppressant tacrolimus.Methods:Liquid SM...
Controlled-release (CR) tablet formulation of olanzapine was developed using a binary mixture of Methocel(R) K100 LV-CR and Ethocel(R) standard 7FP premium by the dry granulation slugging method. Drug...
The objective of this investigation was to develop the cefuroxime axetil sustained-release floating tablets to prolong the gastric residence time and compare their pharmacokinetic behavior with market...
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...