NCT00806416

A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D

A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70 mg Alendronate/2800 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: 244 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	alendronate sodium (+) cholecalciferol	A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
DRUG	Comparator: alendronate	A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
DIETARY_SUPPLEMENT	Comparator: cholecalciferol (Vitamin D)	A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

Timeline

• Start date: 2003-05-01
• Primary completion: 2003-08-01
• Completion: 2004-01-01
• First posted: 2008-12-10
• Last updated: 2022-02-08
• Results posted: 2010-02-12