To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cefdinir 300 mg Capsule (Sandoz, Austria); Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882154

50039

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 56 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

1

Experimental group

Description:

Cefdinir 300 mg Capsule (Sandoz, Austria)

Treatment:

Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)

2

Active Comparator group

Description:

Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Treatment:

Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)