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Sponsors and Collaborators: |
Procter and Gamble Sanofi-Aventis |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00755872 |
This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study. Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and have urine collected over 72 hours following administration of risedronate for all 4 treatment periods).
Condition | Intervention | Phase |
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Bioavailability |
Drug: Risedronate |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study |
Official Title: | Influence of a High-Fat Meal on the Bioavailability of a Two Different Formulations of Risedronate |
Enrollment: | 76 |
Study Start Date: | November 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Treatment A (35 mg DR Fasted): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.
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Drug: Risedronate
Treatment A (35 mg DR Fasted): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.
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2: Experimental
Treatment B (35 mg DR Fed): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, within 5 minutes after ingesting a high-fat meal.
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Drug: Risedronate
Treatment B (35 mg DR Fed): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, within 5 minutes after ingesting a high-fat meal.
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3: Experimental
Treatment C (35 mg IR Fasted): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.
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Drug: Risedronate
Treatment C (35 mg IR Fasted): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.
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4: Experimental
Treatment D (35 mg IR Per-label): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, 30 minutes before ingesting a high-fat meal.
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Drug: Risedronate
Treatment D (35 mg IR Per-label): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, 30 minutes before ingesting a high-fat meal.
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Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion at Admission:
United States, Florida | |
Research Site | |
Ft Myers, Florida, United States | |
Research Site | |
Miramar, Florida, United States | |
United States, Texas | |
Research Site | |
Austin, Texas, United States |
Study Director: | William S Aronstein, MD, PhD | Procter and Gamble |
Responsible Party: | Procter and Gamble Company ( William S Aronstein, MD, PhD ) |
Study ID Numbers: | 2007120 |
Study First Received: | September 18, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00755872 |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Risedronic acid |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |