Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 30, 2002

Primary Completion Date

February 29, 2004

Study Completion Date

February 29, 2004

Conditions
OsteopeniaOsteoporosis
Interventions
DRUG

risedronate

0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks followed by another 14C-labeled risedronate followed weekly by 35 mg risedronate for 3 weeks

DRUG

alendronate

0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks

Trial Locations (2)

Unknown

Research Facility, Gainesville

Research Site, New Orleans

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Warner Chilcott

INDUSTRY