Cefdinir for Oral Suspension 250 mg/5mL, Fasting
Condition: Healthy
Intervention: Cefdinir for oral suspension 250 mg/5mL; OMNICEF® for oral suspension 250 mg/5mL
Intervention description: 1 x 250 mg/5mL, single dose fasting; 1 x 250 mg/5mL, single dose fasting
Intervention MeSH terms: Cefdinir
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to compare the relative bioavailability of cefdinir for oral
      suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of
      OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects
      under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects selected for this study will be non-smokers at least 18 years of age.
             Subjects will have a BMI (body mass index) between 19 kg/m² and 30 kg/m² (inclusive).

          -  Each subject will be given a general physical examination within 28 days of initiation
             of the study. Such examination includes but is not limited to blood pressure, general
             observations, and history.

          -  Each female subject will be given a serum pregnancy test as part of the pre-study
             screening process.

          -  Adequate blood and urine samples should be obtained within 28 days before beginning of
             the first period and at the end of the trial for clinical laboratory measurements.

        Clinical laboratory measurements will include the following:

          -  Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood
             cell count (with differential).

          -  Clinical Chemistry: creatinine, BUN, glucose, SGOT, SGPT, bilirubin, and alkaline
             phosphatase.

          -  Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult
             blood, and cells.

          -  HIV Screen

          -  Hepatitis-B, C Screen

          -  Drugs of Abuse Screen: pre-study and at each dosing period check-in

        Subjects will be selected if all above are normal. Electrocardiograms of all participating
        subjects will be recorded before initiation of the study and filed with each subject's case
        report forms.

        Exclusion Criteria:

          -  Subjects with a history of alcoholism or drug addiction (during past 2 years) or
             serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis,
             epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be
             eligible for this study.

          -  Subjects whose clinical laboratory test values are outside the reference range may be
             retested at the discretion of the clinical investigator. If the clinical values are
             outside the range on retesting, the subject will not be eligible to participate in the
             study unless the clinical investigator deems the result to not be significant.

          -  Subjects who have a history of allergic responses to the class of drug being tested
             (including penicillin, any penicillin derivative, or any cephalosporin product) should
             be excluded from the study.

          -  All subjects will have urine/saliva samples assayed for the presence of drugs of abuse
             as part of the clinical laboratory screening procedures and at each study period
             check-in. Subjects found to have urin/saliva concentrations of any of the tested drugs
             will not be allowed to participate.

          -  Subjects should not have donated blood and/or plasma for at least thirty (30) days
             prior to the first dosing of the study.

          -  Subjects who have taken any investigational drug within thirty (30) days prior to the
             first dosing of the study will not be allowed to participate.

          -  Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant
             during the study will not be allowed to participate. Female subjects of child bearing
             potential must either abstain from sexual intercourse or use a reliable barrier method
             (e.g. condom, IUD) of contraception during the course of the study (first dosing until
             last blood collection) or they will not be allowed to participate. Subjects who have
             used implanted or injected hormonal contraceptives anytime during the 6 months prior
             to study dosing, or used oral hormonal contraceptives within 14 days before dosing
             will not be allowed to participate.

          -  All female subjects will be screened for pregnancy at check-in each study period.
             Subjects with positive or inconclusive results will be withdrawn from the study.

          -  Subjects who do not tolerate venipuncture will not be allowed to participate.

          -  Subjects who use tobacco in any form will not be eligible to participate in the study.
             Three months abstinence is require.

          -  Subjects who have difficulty fasting or consuming the standard meals will not be
             allowed to participate.

          -  Subjects who have had a clinically significant illness within 4 weeks prior to the
             first dosing of the study will not be allowed to participate.

          -  Subjects who have used a known hepatic enzyme inducer or inhibitor within 30 days
             prior to the first dosing of the study will not be allowed to participate.