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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803790
• Other study ID #: 0217A-253
• Secondary ID: 2008_595
• Status: Completed
• Phase: Phase 1
• Start date: May 2006
• Est. completion date: July 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Urinary Excretion of Alendronate	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.	Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)
Primary	Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D	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.	Day 1 across the 80-hour plasma collection period (Period 1 and 2)
Secondary	Part II : Maximum Concentration (Cmax) of Vitamin D	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.	Day 1 across the 80-hour plasma collection period (Periods 1 and 2)