To Demonstrate the Relative Bioequivalence of Cefdinir an... | NCT00883883

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

NCT00883883

Sponsor

Sandoz

Status

Completed

Last Update Posted

Mar 29, 2017Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official 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 Fed State

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Apr 16, 2009

First Submission Date that Met QC Criteria

Apr 17, 2009

First Posted Date

Apr 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 29, 2017Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)	Drug: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
2	Active Comparator	Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)	Drug: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)	Drug		1
Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)

Measure	Description	Time Frame
Bioequivalence based on AUC and Cmax		15 days

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

56 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Benoit Girard, M.D.	SFBC Anapharm	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D000077525	Cefdinir
D013535	Suspensions

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided