Clinical trial NCT00835406: Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility 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.

Primary outcomes:
measure: Bioequivalence Based on Rmax
timeFrame: Urine collected over 36 hour period
measure: Bioequivalence Based on Ae0-36
timeFrame: Urine collected over 36 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Sainte-Foy
country: Canada
facility: Anapharm Inc.
state: Quebec
Study officials:
affiliation: Anapharm
name: Eric Masson, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: