At a glance
ClinicalIndex Comparison Record- ✓Males aged 18-45 years, non-smokers
- ✓Weight within 15% of ideal body weight per Metropolitan Life Insurance Company 1983 table
- ✓All screening procedures completed within 28 days prior to study medication administration
- ✕Any clinically significant abnormalities on medical screening or laboratory tests
- ✕History or presence of significant neurological, hepatic, renal, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease
- ✕History of gastrointestinal problems interfering with drug absorption, distribution, metabolism or excretion (e.g., chronic diarrhea, inflammatory bowel diseases)
- ✕Clinically significant illness within 4 weeks of study medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Alendronate Sodium Tablets 70mg and Fosamax® Tablets 70mg for Healthy. Completed, enrolled 140 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
1 x 70mg, single dose fasting
1 x 70 mg, single dose fasting