To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions

March 27, 2017 updated by: Sandoz

A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fed State

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 56 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
Drug: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
ACTIVE_COMPARATOR: 2
Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)
Drug: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioequivalence based on AUC and Cmax
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

May 1, 2005

Study Completion (ACTUAL)

May 1, 2005

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 17, 2009

First Posted (ESTIMATE)

April 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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