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

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.

Inclusion Criteria:

• Male or nonpregnant female age 18 to 65 years
• Female of childbearing potential on appropriate method of contraception and not nursing
• BMI (body mass index) less than or equal to 30 kg/m2
• Subject is in good health
• Willing to limit direct sunlight and apply sunscreen if in the sun more than 1 hour

Exclusion Criteria:

• mental or legal incapacitation
• received bisphosphonate treatment within 3 months of screening
• unable to sit or stand upright for at least 2 hours