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Trials / Completed

CompletedNCT00882700

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fasting State

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Sandoz · Industry
Sex
All
Age
18 Years – 56 Years
Healthy volunteers
Accepted

Summary

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.

Conditions

Interventions

TypeNameDescription
DRUGCefdinir 300 mg Capsule (Sandoz, Austria)
DRUGOmnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Timeline

Start date
2005-04-01
Primary completion
2005-04-01
Completion
2005-04-01
First posted
2009-04-16
Last updated
2017-03-29

Source: ClinicalTrials.gov record NCT00882700. Inclusion in this directory is not an endorsement.

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions (NCT00882700) · Clinical Trials Directory