Status:
COMPLETED
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Lead Sponsor:
Organon and Co
Conditions:
Osteoporosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 alendro...
Eligibility Criteria
Inclusion
- 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
- mental or legal incapacitation
- received bisphosphonate treatment within 3 months of screening
- unable to sit or stand upright for at least 2 hours
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00806416
Start Date
May 1 2003
End Date
January 1 2004
Last Update
February 8 2022
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