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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00400530 |
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.
Condition | Intervention | Phase |
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Osteoporosis |
Drug: MK0217, alendronate sodium / Duration of Treatment: 1 Month Drug: Comparator: Alendronate-Teva / Duration of Treatment: 1 Month |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets |
Ages Eligible for Study: | 55 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2006_050 |
Study First Received: | November 16, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00400530 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Musculoskeletal Diseases Alendronate Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Alendronate Physiological Effects of Drugs Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |