At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3
In Brief
A Phase 1 clinical trial evaluating alendronate sodium+vitamin D combination, Comparator: alendronate, and 1 other intervention for Osteoporosis. Completed, enrolled 318 participants.
Detailed Summary
This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone. This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.
Study Details
Timeline
Interventions
A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.
A single dose tablet of 70mg alendronate in one treatment period of each sequence.
Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.