NCT00881400

Brief Summary

To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
4.9 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

Same day

First QC Date

April 14, 2009

Last Update Submit

March 27, 2017

Conditions

Healthy

Keywords

Antibiotic

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    15 days

Study Arms (2)

1

EXPERIMENTAL

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

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

2

ACTIVE COMPARATOR

Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)

Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)

Interventions

Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)DRUG
1
Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (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

CefprozilSuspensions

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Magdy L. Shenouda, 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

June 1, 2004

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

March 29, 2017

Record last verified: 2009-04