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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00806416

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: alendronate sodium (+) cholecalciferol Drug: Comparator: alendronate Dietary Supplement: Comparator: cholecalciferol	Phase I

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Part 1: Compare the urinary excretion of alendronate with alendronate/vitamin D combination tablet relative to alendronate tablet Part 2: compare the pharmacokinetic parameters of vitamin D in combination tablet relative to vitamin D tablet [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	236
Study Start Date:	May 2003
Study Completion Date:	January 2004
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sequence 1: Experimental alendronate/vitamin D combination then alendronate	Drug: alendronate sodium (+) cholecalciferol A single dose tablet of 70mg alendronate/2800 IU 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 70mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
Sequence 2: Experimental alendronate then alendronate/vitamin D combination	Drug: alendronate sodium (+) cholecalciferol A single dose tablet of 70mg alendronate/2800 IU 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 70mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period.
Sequence 3: Experimental alendronate/vitamin D combination then vitamin D	Drug: alendronate sodium (+) cholecalciferol A single dose tablet of 70mg alendronate/2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. Dietary Supplement: Comparator: cholecalciferol 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.
Sequence 4: Experimental vitamin D then alendronate/vitamin D combination	Drug: alendronate sodium (+) cholecalciferol A single dose tablet of 70mg alendronate/2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. Dietary Supplement: Comparator: cholecalciferol 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806416

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_596, MK0217A-226
Study First Received:	December 9, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00806416
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cholecalciferol
Vitamin D
Musculoskeletal Diseases
Alendronate

Ergocalciferols
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009