MedPath

Upper GI Handling of Branded vs. Generic Alendronate

Phase 3
Completed
Conditions
Osteoporosis
Registration Number
NCT00400530
Lead Sponsor
Merck Sharp & Dohme LLC
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
25
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
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Exclusion Criteria
  • History of drug hypersensitivity
  • Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Gamma camera imaging of tablet dissolution in oesophagus
Secondary Outcome Measures
NameTimeMethod
Gamma camera dissolution of tablets in stomach
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