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A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00803790
First received: December 4, 2008
Last updated: September 28, 2016
Last verified: September 2016
December 4, 2008
September 28, 2016
May 2006
July 2006   (Final data collection date for primary outcome measure)
  • Part 1: Urinary Excretion of Alendronate [ Time Frame: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2) ]
    Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. 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 Days 1 and 2.
  • Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D [ Time Frame: Day 1 across the 80-hour plasma collection period (Period 1 and 2) ]
    The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
Part 1: Compare the urinary excretion of alendronate with alendronate/vitamin D combination tablet relative to alendronate tablet. Part 2: compare the pharmacokinetic parameter, AUC, of vitamin D in combination tablet relative to vitamin D tablet. [ Time Frame: Approximately 8 weeks ]
Complete list of historical versions of study NCT00803790 on ClinicalTrials.gov Archive Site
Part II : Maximum Concentration (Cmax) of Vitamin D [ Time Frame: Day 1 across the 80-hour plasma collection period (Periods 1 and 2) ]
Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
Compare the pharmacokinetic parameter, Cmax, of vitamin D in combination tablet relative to vitamin D tablet. [ Time Frame: Approximately 8 weeks ]
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A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)
A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3

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 vitamin D alone.

This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoporosis
  • Drug: alendronate sodium+vitamin D combination
    A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.
  • Drug: Comparator: alendronate
    A single dose tablet of 70mg alendronate in one treatment period of each sequence.
  • Dietary Supplement: Comparator: Vitamin D
    Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.
  • Experimental: Sequence 1- alendronate+vitamin D combination then alendronate
    Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
    Interventions:
    • Drug: alendronate sodium+vitamin D combination
    • Drug: Comparator: alendronate
  • Experimental: Sequence 2 alendronate then alendronate+vitamin D combination
    Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
    Interventions:
    • Drug: alendronate sodium+vitamin D combination
    • Drug: Comparator: alendronate
  • Experimental: Sequence 3 alendronate+vitamin D combination then vitamin D
    Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
    Interventions:
    • Drug: alendronate sodium+vitamin D combination
    • Dietary Supplement: Comparator: Vitamin D
  • Experimental: Sequence 4- vitamin D then alendronate+vitamin D combination
    Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
    Interventions:
    • Drug: alendronate sodium+vitamin D combination
    • Dietary Supplement: Comparator: Vitamin D
Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
July 2006
July 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00803790
0217A-253
2008_595
Not Provided
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP