- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00806416
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1
alendronate/vitamin D combination then alendronate
|
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.
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.
|
Experimental: Sequence 2
alendronate then alendronate/vitamin D combination
|
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.
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.
|
Experimental: Sequence 3
alendronate/vitamin D combination then vitamin D
|
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.
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.
|
Experimental: Sequence 4
vitamin D then alendronate/vitamin D combination
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet
Time Frame: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).
|
Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet.
Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.
|
On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).
|
Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
Time Frame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
|
Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose. |
On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
|
Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
Time Frame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
|
Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.
Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.
|
On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0217A-226
- 2008_596
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