Phase 1
Completed N=214
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Source: ClinicalTrials.gov NCT00806416 ↗Enrolled (actual)
214
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet — 197.5; 191.9 micrograms (μg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet |
197.5; 191.9 | — |
| PRIMARY Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet |
296.4; 337.9 | — |
| PRIMARY Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet |
5.9; 6.6 | — |
Eligibility 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 (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
- mental or legal incapacitation
- received bisphosphonate treatment within 3 months of screening
- unable to sit or stand upright for at least 2 hours
Data sourced from ClinicalTrials.gov (NCT00806416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.