Upper GI Handling of Branded vs. Generic Alendronate

A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400530

Enrollment

Registered

2006-11-17

Start date

2005-12-31

Completion date

Unknown

Last updated

2006-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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.

Interventions

DRUGMK0217, alendronate sodium / Duration of Treatment: 1 Month

DRUGComparator: Alendronate-Teva / Duration of Treatment: 1 Month

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Gamma camera imaging of tablet dissolution in oesophagus	—

Secondary

Measure	Time frame
Gamma camera dissolution of tablets in stomach	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026