A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
Condition: Infections, Urinary Tract
MeSH terms: Urinary Tract Infections
Intervention: Cefadroxil tablets manufactured by GSK; Cefadroxil tablets manufactured by NP
Intervention description: Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil; Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil
Intervention MeSH terms: Cefadroxil
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; film coated tablets; cefadroxil

Summary:

      This is an open-label, randomized, single dose, two-sequence two-period crossover study,
      separated by 7 days washout interval from the first Study Drug Administration. This study is
      conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets
      manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and
      cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm &amp;Chem .Ind.
      Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy
      adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive
      cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days,
      subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not
      receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a
      trademark of Sandoz.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female, age 18 to 55 years, inclusive.

          -  Body weight within 15 percent of normal range according to the accepted normal values
             for body mass index (BMI).

          -  Medical demographics without evidence of clinically significant deviation from normal
             medical condition.

          -  Results of clinical laboratory test are within the normal range or with a deviation
             that is not considered clinically significant by principal investigator.

          -  Subject does not have allergy to the drugs under investigation.

        Exclusion Criteria:

          -  Subjects with known allergy to the products tested.

          -  Subjects whose values of BMI were outside the accepted normal ranges.

          -  Female subjects who were pregnant, nursing or taking birth control pills.

          -  Medical demographics with evidence of clinically significant deviation from normal
             medical condition.

          -  Results of laboratory tests which are clinically significant.

          -  Acute infection within one week preceding first study drug administration.

          -  History of drug or alcohol abuse.

          -  Subject does not agree not to take any prescription or non-prescription drugs within
             two weeks before first study drug administration and until the end of the study.

          -  Subject is on a special diet (for example subject is vegetarian).

          -  Subject does not agree not to consume any beverages or foods containing
             methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to
             the study administration of either study period until donating the last sample in each
             respective period.

          -  Subject does not agree not to consume any beverages or foods containing grapefruit 7
             days prior to first study drug administration until the end of the study.

          -  Subject has a history of severe diseases which have direct impact on the study.

          -  Participation in a bioequivalence study or in a clinical study within the last 6 weeks
             before first study drug administration.

          -  Subject intends to be hospitalized within 6 weeks after first study drug
             administration.

          -  Subjects who, through completion of this study, would have donated more than 500
             milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days,
             1250 mL in 120 days, 1500 mL in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1
             year.