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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835406
First received: January 30, 2009
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Alendronate Sodium Tablets 70mg
Drug: Fosamax® Tablets 70mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence Based on Rmax [ Time Frame: Urine collected over 36 hour period ] [ Designated as safety issue: No ]
  • Bioequivalence Based on Ae0-36 [ Time Frame: Urine collected over 36 hour period ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: June 2000
Study Completion Date: July 2000
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835406

Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada, GIV2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Eric Masson, Pharm.D. Anapharm
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00835406     History of Changes
Other Study ID Numbers: 00161
Study First Received: January 30, 2009
Results First Received: April 24, 2009
Last Updated: June 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014