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

Phase 1CompletedNCT00882570

Sandoz40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 56 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 10 days

Data from ClinicalTrials.gov

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