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Cefdinir Capsules 300 mg, Non-fasting

NCT00834535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-08-20

Study results available
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Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 300 mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a single oral dose (1 x 300mg capsule) in healthy adult subjects administered under non-fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Cefdinir Capsules 300 mg

1 x 300 mg, single-dose non-fasting

DRUG

OMNICEF® Capsule 300 mg

1 x 300 mg, single-dose non-fasting

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • James D. Carlson, Pharm. D. · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00834535 on ClinicalTrials.gov