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

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Alendronate; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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