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A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00806416
First received: December 9, 2008
Last updated: April 6, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoporosis
 Drug: alendronate sodium (+) cholecalciferol
Drug: Comparator: alendronate
Dietary Supplement: Comparator: cholecalciferol (Vitamin D)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: No ]

    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.


  • 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). ] [ Designated as safety issue: No ]
    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.


Enrollment: 244
Study Start Date: May 2003
Study Completion Date: January 2004
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
alendronate/vitamin D combination then alendronate
 Drug: 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.
Drug: 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.
Experimental: Sequence 2
alendronate then alendronate/vitamin D combination
 Drug: 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.
Drug: 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.
Experimental: Sequence 3
alendronate/vitamin D combination then vitamin D
 Drug: 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.
Dietary Supplement: 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.
Experimental: Sequence 4
vitamin D then alendronate/vitamin D combination
 Drug: 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.
Dietary Supplement: 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806416

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00806416     History of Changes
Other Study ID Numbers: 2008_596, MK0217A-226
Study First Received: December 9, 2008
Results First Received: January 8, 2010
Last Updated: April 6, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Alendronate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013