Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
Condition: Healthy
Intervention: Alendronate Sodium Tablets 70mg; Fosamax® Tablets 70mg
Intervention description: 1 x 70mg, single dose fasting; 1 x 70 mg, single dose fasting
Intervention MeSH terms: Alendronate
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to compare the rate and extent of absorption of alendronate
      sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a
      single dose of 70 mg under fasting conditions. A review of pharmacokinetic data demonstrates
      Alendronate Sodium Tablets, 70 mg, manufactured and distributed by TEVA Pharmaceuticals USA
      are bioequivalent to Fosamax® Tablets, 70 mg, manufactured by Merck Sharp & Dohme, USA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be males, non-smokers, between 18 and 45 years of age.

          -  Subjects' weight will be within 15% of their ideal body weight based on the Table of
             "Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983

          -  Subjects should read, sign, and date an Informed Consent Form prior to any study
             procedures.

          -  Subjects must complete all screening procedures within 28 days prior to the
             administration of study medication.

        Exclusion Criteria:

          -  Clinically significant abnormalities found during medical screening.

          -  Any history or presence of significant neurological, hepatic, renal, endocrine,
             cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

          -  Any clinically significant history of ongoing gastrointestinal problems or problems
             known to interfere with the absorption, distribution, metabolism or excretion of drugs
             (e.g. chronic diarrhea, inflammatory bowel diseases).

          -  Clinically significant illnesses within 4 weeks of the administration of study
             medication.

          -  Abnormal laboratory tests judged clinically significant.

          -  ECG or vital signs abnormalities (clinically significant).

          -  History of allergic reactions to alendronate or other related drugs (e.g. clodronate,
             etidronate and pamidronate).

          -  History of allergic reactions to heparin.

          -  Any food allergies, intolerances, restrictions, or special diet which in the opinion
             of the medical subinvestigator, contraindicates the subject's participation in this
             study.

          -  Positive urine drug screen at screening or at check-in of period I.

          -  Positive testing for hepatitis B, hepatitis C or HIV at screening.

          -  Use of an investigational drug or participation in an investigational study, within 30
             days prior to administration of the study medication.

          -  Recent donation of plasma (500 mL) within 7 days or recent donation or significant
             loss of whole blood (450 mL) within 56 days prior to administration of the study
             medication.

          -  History of significant alcohol abuse within six months of the screening visit or any
             indication of the regular use of more than two units of alcohol per day (1 Unit =
             150mL of wine or 360 mL of beer or 45 mL of alcohol 40%).

          -  Recent history of drug abuse or use of illegal drugs: use of soft drugs (such as
             marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine,
             phencyclidine (PCP), crack) within 1 year of the screening visit.

          -  Subjects who have used tobacco within 90 days of the start of the study.

          -  Subjects who have taken prescription medication 14 days preceding administration of
             study medication or over-the-counter products 7 days preceding administration of study
             medication, except for topical products without systemic absorption.

          -  Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism
             within 30 days prior to administration of the study medication (examples of inducers:
             barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples
             of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO
             inhibitors, neuroleptics, verapamil, quinidine).

          -  Subjects who have undergone clinically significant surgery 4 weeks prior to the
             administration of the study medication.

          -  Any reason which, in the opinion of the medical subinvestigator, would prevent the
             subject from participating in the study.