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

Condition(s) targeted: Osteoporosis

Intervention: alendronate sodium (+) cholecalciferol (Drug); Comparator: alendronate (Drug); Comparator: cholecalciferol (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 (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

Official title: 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

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

Primary outcome:

Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet

Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet

Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Starting date: May 2003
Last updated: July 31, 2015