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CompletedNCT00882570Updated Mar 29, 2017

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

A Phase 1 interventional study of Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria) and Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA) in Healthy, sponsored by Sandoz. Completed. Open to participants aged 18 Years to 56 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by Sandoz · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 56 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Antibiotic
03

In context

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 56 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    1

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

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

  • Active comparator
    2

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

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

Interventions

  • DrugCefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria)
  • DrugOmnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
06

What researchers measure

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 10 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00882570
Lead sponsor
Sandoz
First posted
Apr 16, 2009
Start date
Apr 2005
Primary completion
May 2005
Completion
May 2005
Last update
Mar 29, 2017

Study contacts

Richard Larouche, M.D.
principal investigator · SFBC Anapharm
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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