Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
Status:
Completed
Trial end date:
2000-07-01
Target enrollment:
Participant gender:
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.