NCT00881855

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
Last Updated

March 29, 2017

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

April 14, 2009

Last Update Submit

March 27, 2017

Conditions

Healthy

Keywords

Antibiotics

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    15 days

Study Arms (2)

1

EXPERIMENTAL

Cefprozil 500 mg Tablets (Sandoz, GmbH)

Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH)

2

ACTIVE COMPARATOR

Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)

Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)

Interventions

Cefprozil 500 mg Tablets (Sandoz, GmbH)DRUG
1
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)DRUG
2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cefprozil

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gaetano Morelli, M.D.

    MDS Pharma Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

March 1, 2004

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

March 29, 2017

Record last verified: 2009-04