NCT00806416View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

May 31, 2003

Primary Completion Date

August 31, 2003

Study Completion Date

January 31, 2004

Conditions
Osteoporosis
Interventions
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.

DRUG

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.

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00806416 - A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D | Biotech Hunter | Biotech Hunter