drugset / Trial / NCT00983996

Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)

NCT00983996

Phase 1 Completed 112 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-label

Summary

The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administration under fasting conditions.

Timeline

Start
2002-06
Primary completion
2002-07
Completion
2002-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alendronic Acid Small molecule 10 mg Oral

Indications

No indication recorded.