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

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Alendronate Sodium Tablets 70mg (Drug); Fosamax® Tablets 70mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Eric Masson, Pharm.D., Principal Investigator, Affiliation: Anapharm


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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Bioequivalence Based on Rmax

Bioequivalence Based on Ae0-36

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


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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


- 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


- 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.

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec GIV2K8, Canada
Additional Information

Starting date: June 2000
Last updated: June 29, 2009

Page last updated: August 20, 2015

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