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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Male or nonpregnant female age 18 to 85 years

• female of childbearing potential on appropriate method of contraception and not nursing

• Body Mass Index (BMI) less than or equal to 30 kg/m2

• subject is in good health

Exclusion Criteria:

• mental or legal incapacitation

• received bisphosphonate treatment within 3 months of enrollment.

• unable to sit or stand upright for at least 2 hours

• unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration

• unwilling to limit alcohol consumption to no more than 2 drinks per day

• unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent.

• unwilling to refrain from smoking during the study