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OpenTrials
Completed

NCT Number: NCT00882570

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)

Drug

Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

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 Fasting State

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 16, 2009
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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