Advertisement

Topics

Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions

2014-08-27 03:26:45 | BioPortfolio

Summary

The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.

Description

A single dose, randomized, two-period, two-treatment, two-sequence crossover study design was used to evaluate the relative bioavailability of the cefprozil tablet products when dosed (1 x 500 mg) under fed conditions. The washout period will be at least 14 days between doses.

Twenty four plus two alternate (24 + 2) subjects were enrolled in this study and all volunteers were healthy adults. Twenty six (24 + 2) subjects began the study, and twenty-five (23 + 2) subjects completed the clinical portion of the study in its entirety.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

cefprozil 500mg tablets

Location

MDS Pharma Services
Montreal
Quebec
Canada
H4R2N6

Status

Completed

Source

Ranbaxy Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:45-0400

Clinical Trials [1022 Associated Clinical Trials listed on BioPortfolio]

Cefprozil 500 mg Tablets Under Fed Conditions

The objective of this study is to compare the relative bioavailability of cefprozil 500 mg tablets with that of Cefzil 500 mg tablets in healthy, non-smoking adults under non-fasting condi...

To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions

The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.

To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting conditions.

Bioequivalence Study of Co-codamol 15mg/500mg Capsules vs Co-codamol 30mg/500mg Tablets in Healthy Subjects

The purpose of this study is to compare the bioavailability of co-codamol 15mg/500mg capsules (test product) and co-codamol 30mg/500mg tablets (reference product).

Bioequivalence Study of Clarithromycin 500mg Tablets Under Fasting Conditions.

The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adul...

PubMed Articles [4631 Associated PubMed Articles listed on BioPortfolio]

Effect of Crushing, Cutting into Half, or Grinding of Co-formulated Glecaprevir/Pibrentasvir Tablets on Pharmacokinetic Measurements in Healthy Subjects.

Glecaprevir (GLE) and pibrentasvir (PIB) are direct-acting antivirals coformulated as a combination tablet for once-daily treatment of chronic hepatitis C virus infection. The objective of this study ...

Tablets made from paper.

The possibility to compress ordinary paper into tablets was systematically investigated in this study. Results proved that tablets can be made from paper, independent of the type of paper used. The ta...

Content uniformity of quartered hydrocortisone tablets in comparison with mini-tablets for paediatric dosing.

Children requiring cortisol replacement therapy are often prescribed hydrocortisone doses of 2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split c...

Defined drug release from 3D-printed composite tablets consisting of drug-loaded polyvinylalcohol and a water-soluble or water-insoluble polymer filler.

3D-printed tablets are a promising new approach for personalized medicine. In this study, we fabricated composite tablets consisting of two components, a drug and a filler, by using a fused deposition...

Inhibition of Gastric H,K-ATPase Activity in Vitro by Dissolution Media of Original Brand-Name and Generic Tablets of Lansoprazole, a Proton Pump Inhibitor.

To investigate the inhibitory effect of a commercial proton pump inhibitor (lansoprazole) on the gastric proton pump H,K-ATPase in vitro, we used orally disintegrating (OD) tablets including original ...

Medical and Biotech [MESH] Definitions

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

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.

A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.

More From BioPortfolio on "Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial