Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.

Launched by TEVA PHARMACEUTICALS USA · Jan 30, 2009

Keywords

ClinConnect Summary

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Gender

MALE

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.