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

Organon and Co244 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

244

Conditions

Osteoporosis

Interventions

alendronate sodium (+) cholecalciferolDRUG

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: alendronateDRUG

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.

Comparator: cholecalciferol (Vitamin D)DIETARY_SUPPLEMENT

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

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).

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.

Time frame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).

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.

Time frame: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).

Data from ClinicalTrials.gov

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