Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Fexofenadine 180 mg tablets; ALLEGRA® 180 mg tablets
Intervention description: 1 x 180 mg; 1 x 180 mg
Intervention MeSH terms: Fexofenadine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      This study will compare the relative bioavailability (rate and extent of absorption) of 180
      mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.
      with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral
      dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All volunteers selected for this study will be healthy, non-smoking men and women 18
             to 55 years of age, inclusive, at the time of dosing. The volunteer's body mass index
             (BMI) is less that or equal to 30.

          -  If female and :

               -  of child bearing potential, is practicing an acceptable method of birth control
                  for the duration of the study as judged by the investigator(s), such as condoms,
                  foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or

               -  is postmenopausal for at least 1 year; or

               -  is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
                  hysterectomy).

        Exclusion Criteria:

          -  Volunteers with a recent history of drug or alcohol addiction or abuse.

          -  Volunteers with the presence of a clinically significant disorder involving the
             cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
             endocrine, or neurologic system(s) or psychiatric disease (as determined by the
             clinical investigators).

          -  Volunteers whose clinical laboratory test values are outside the accepted reference
             range and when confirmed on re-examination are deemed to be clinically significant.

          -  Volunteers demonstration a positive hepatitis B surface antigen screen, hepatitis C
             antibody screen or a reactive HIV antibody screen.

          -  Volunteers demonstrating a positive drug abuse screen when screened for this study.

          -  Female volunteers who are currently breast feeding.

          -  Female volunteers who are demonstrating a positive pregnancy screen.

          -  Volunteers with a history of allergic response(s) to fexofenadine or related drugs.

          -  Volunteers with a history of clinically significant allergies including drug
             allergies.

          -  Volunteers with a clinically significant illness during the 4 weeks prior to Period I
             dosing (as determined by the clinical investigators).

          -  Volunteers who currently use or reports using tobacco or nicotine-containing products
             within 90 days prior to Period I dosing.

          -  Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism
             in the 30 days prior to Period I dosing.

          -  Volunteers who report donating greater than 150 mL of blood within 30 days prior to
             Period I dosing. All subjects will by advised not to donate blood for four weeks after
             completing the study.

          -  Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to
             Period I dosing. All subjects will be advised not to donate plasma for four weeks
             after completing the study.

          -  Volunteers who report receiving any investigational drug within 30 days prior to
             Period I dosing.

          -  Volunteers who report taking any prescription medication in the 14 days prior to
             Period I dosing, with the exception of topical products without systemic absorption.

          -  Volunteers who have been on an abnormal diet during the 28 days prior to Period I
             dosing.

          -  Volunteers who report an intolerance of direct venipuncture.