To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

Phase 1CompletedNCT00882700

Sandoz28 enrolled

Overview

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Cefdinir 300 mg Capsule (Sandoz, Austria)DRUG

Omnicef Cefdinir 300 mg Capsule (Abbott 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: 14 days

Data from ClinicalTrials.gov

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