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

NCT ID: NCT00835406

Last Updated: 2009-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2000-07-31

Brief 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.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Alendronate Sodium First

70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period

Group Type: EXPERIMENTAL

Alendronate Sodium Tablets 70mg

Intervention Type: DRUG

1 x 70mg, single dose fasting

Fosamax® First

70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.

Group Type: ACTIVE_COMPARATOR

Fosamax® Tablets 70mg

Intervention Type: DRUG

1 x 70 mg, single dose fasting

Interventions

Alendronate Sodium Tablets 70mg

1 x 70mg, single dose fasting

Intervention Type: DRUG

Fosamax® Tablets 70mg

1 x 70 mg, single dose fasting

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Eric Masson, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

Anapharm Inc.

Sainte-Foy, Quebec, Canada

Countries

Canada

Other Identifiers

00161

Identifier Type: -

Identifier Source: org_study_id