A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
NCT ID: NCT00806416
Last Updated: 2022-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
244 participants
INTERVENTIONAL
2003-05-31
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
alendronate/vitamin D combination then alendronate
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.
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.
Sequence 2
alendronate then alendronate/vitamin D combination
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.
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.
Sequence 3
alendronate/vitamin D combination then vitamin D
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.
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.
Sequence 4
vitamin D then alendronate/vitamin D combination
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* received bisphosphonate treatment within 3 months of screening
* unable to sit or stand upright for at least 2 hours
18 Years
65 Years
ALL
Yes
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.
Other Identifiers
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2008_596
Identifier Type: -
Identifier Source: secondary_id
0217A-226
Identifier Type: -
Identifier Source: org_study_id
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