NCT00803790

A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	alendronate sodium+vitamin D combination	A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.
DRUG	Comparator: alendronate	A single dose tablet of 70mg alendronate in one treatment period of each sequence.
DIETARY_SUPPLEMENT	Comparator: Vitamin D	Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2008-12-08
• Last updated: 2022-02-03
• Results posted: 2011-05-09