Upper GI Handling of Branded vs. Generic Alendronate

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Alendronate

Criteria

Inclusion Criteria:

• Post-menopausal females aged greater 55 years

• Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study

• Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day

• Willing to abstain from smoking for 24 hours before each dose and until the end of each study day

Exclusion Criteria:

• History of drug hypersensitivity

• Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility