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

NCT00806416 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2022-02-08

Study results available
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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.

Conditions

Interventions

DRUG

alendronate sodium (+) cholecalciferol

A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

DRUG

Comparator: alendronate

A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

DIETARY_SUPPLEMENT

Comparator: cholecalciferol (Vitamin D)

A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2003-08-31
Completion
2004-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806416 on ClinicalTrials.gov