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

Randomized, 2-Way Crossover, Bioequivalence Study of Teva Pharmaceuticals USA and Merck Sharp & Dohme (USA) (Fosamax®) Alendronate Sodium Tablets Administered as a 1 x 70 mg in Healthy Adult Males Under Fasting Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Alendronate Sodium Tablets 70mg; Drug: Fosamax® Tablets 70mg

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada, GIV2K8
      • Anapharm Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Alendronate Sodium Tablets 70mg; 1 x 70mg, single dose fasting
Active Comparator: 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.	Drug: Fosamax® Tablets 70mg; 1 x 70 mg, single dose fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence Based on Rmax	Rmax = maximum rate of urinary excretion	Urine collected over 36 hour period
Bioequivalence Based on Ae0-36	Ae0-36 = cumulative urine excretion	Urine collected over 36 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Eric Masson, Pharm.D., Anapharm

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): July 1, 2000
• Study Completion (Actual): July 1, 2000

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2009
• Last Update Submitted That Met QC Criteria: June 29, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: 00161