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

Condition(s) targeted: Osteoporosis

Intervention: alendronate sodium+vitamin D combination (Drug); Comparator: alendronate (Drug); Comparator: Vitamin D (Dietary Supplement)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Part 1: Urinary Excretion of Alendronate

Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D

Secondary outcome: Part II : Maximum Concentration (Cmax) of Vitamin D

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Starting date: May 2006
Last updated: April 14, 2011