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.
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.
