To Demonstrate the Relative Bioequivalence of Cefdinir an... | NCT00882570

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 Fasting State

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

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

Measure	Description	Time Frame
Bioequivalence based on AUC and Cmax		10 days

Eligibility Module

Name	Affiliation	Role
Richard Larouche, M.D.	SFBC Anapharm	Principal Investigator

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
D000077525	Cefdinir
D013535	Suspensions

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003102	Colloids
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations