Status:
COMPLETED
Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 ...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2000
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00835406
Start Date
June 1 2000
End Date
July 1 2000
Last Update
July 9 2009
Active Locations (1)
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1
Anapharm Inc.
Sainte-Foy, Quebec, Canada, GIV2K8