drugset / Trial / NCT00835406
Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
RandomizedCrossoverOpen-label
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.
Timeline
- Start
- 2000-06
- Primary completion
- 2000-07
- Completion
- 2000-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alendronic Acid | Small molecule | 70 mg | — |
Indications
No indication recorded.