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

NCT00835406 | Completed Phase 1 Results

• 1 other identifier: 00161
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Alendronate Sodium First

EXPERIMENTAL

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

Fosamax® First

ACTIVE COMPARATOR

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

Interventions

Alendronate Sodium Tablets 70mg DRUG

1 x 70mg, single dose fasting

Alendronate Sodium First

Fosamax® Tablets 70mg DRUG

1 x 70 mg, single dose fasting

Fosamax® First

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, GIV2K8, Canada

Location

MeSH Terms

Interventions

Alendronate

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Eric Masson, Pharm.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: June 1, 2000
• Primary Completion: July 1, 2000
• Study Completion: July 1, 2000
• Last Updated: July 9, 2009
• Results First Posted: June 11, 2009

Record last verified: 2009-06

Locations

CA (1)