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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

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.

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

Eligibility

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

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.

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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