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

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: alendronate sodium (+) cholecalciferol

• Registration Number: NCT00806416
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2003-08
• Study Completion: 2004-01
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Results First Submitted: 2010-01-08
• Results First Submitted QC: 2010-01-08
• Results First Posted: 2010-02-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	alendronate sodium (+) cholecalciferol	alendronate/vitamin D combination then alendronate
Sequence 4	alendronate sodium (+) cholecalciferol	vitamin D then alendronate/vitamin D combination
Sequence 2	alendronate sodium (+) cholecalciferol	alendronate then alendronate/vitamin D combination
Sequence 3	alendronate sodium (+) cholecalciferol	alendronate/vitamin D combination then vitamin D

Primary Outcome Measures

Name	Time	Method
Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet	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.
Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet	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.
Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet	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.