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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806416
• Other study ID #: 0217A-226
• Secondary ID: 2008_596
• Status: Completed
• Phase: Phase 1
• Start date: May 2003
• Est. completion date: January 2004

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 (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: January 2004
• Est. primary completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.

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.

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: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet	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).
Primary	Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet	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).
Primary	Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet	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).