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

Teva Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Alendronate Sodium Tablets 70mg

Drug: Fosamax® Tablets 70mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00835406

00161

Details and patient eligibility

About

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.

Full description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Enrollment

140 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.