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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2000

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Interventions

  • Drug: Alendronate Sodium Tablets 70mg
    • 1 x 70mg, single dose fasting
  • Drug: Fosamax® Tablets 70mg
    • 1 x 70 mg, single dose fasting

Arms, Groups and Cohorts

  • 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
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Teva Pharmaceuticals USA
  • Overall Official(s)
    • Eric Masson, Pharm.D., Principal Investigator, Anapharm

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