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

Study Overview
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Brief Summary
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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
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Alendronate Sodium Tablets 70mg
* Drug: Fosamax® Tablets 70mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alendronate Sodium First<br>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<br>* 1 x 70mg, single dose fasting<br>|
| Active Comparator: Fosamax® First<br>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<br>* 1 x 70 mg, single dose fasting<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects