Status:
COMPLETED
A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)
Lead Sponsor:
Organon and Co
Conditions:
Osteoporosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
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 v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00803790
Start Date
May 1 2006
End Date
July 1 2006
Last Update
February 3 2022
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