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Assess the Influence of a High-Fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate
This study has been completed.
Sponsors and Collaborators: Procter and Gamble
Sanofi-Aventis
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00755872
  Purpose

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
Bioavailability
Drug: Risedronate
Phase I

Drug Information available for: Risedronate sodium Risedronic acid
U.S. FDA Resources
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

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • The primary objective of this study is to assess the relative bioavailability of the 35 mg DR risedronate tablet administered immediately after a high-fat meal compared to the 35 mg IR risedronate tablet administered 30 minutes prior to a high-fat meal. [ Time Frame: 4 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the relative bioavailability of a 35 mg DR risedronate tablet administered immediately after a high-fat meal compared to the same 35 mg DR risedronate tablet administered under fasted conditions. [ Time Frame: 4 Days ] [ Designated as safety issue: No ]

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
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.
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.
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.
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.
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females 40 - 70 years at time of first dose
  • BMI less than or equal to 32 kg/square meter
  • Non-lactating and either surgically sterile or postmenopausal

Exclusion Criteria:

  • Clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
  • Had a major surgical operation requiring inpatient hospitalization within 1 month prior to screening or plans to have a major surgical operation during the course of the study
  • A history of cancer within the past 5 years, except for basal cell carcinoma with documentation of a 6-month remission at screening. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded, provided there is documentation of a 12-month remission
  • Any disease or surgery known to alter normal gastrointestinal structure or function
  • A history of gastrointestinal disease (peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, irritable bowel syndrome, or moderate to severe gastro-esophageal reflux disease that requires prescription or frequent [> 3 times/week] nonprescription medicinal intervention [eg, antacids])
  • A history of gastrointestinal surgery, with the exception of appendectomy and hernia repair that did not require bowel resection (subjects who have undergone appendectomy or hernia repair within the 12 months prior to screening will be excluded from the study)
  • Acute gastritis, diarrhea or constipation within the 14-day period prior to the predicted first dosing day. If screening occurs >14 days before the first dosing day, subjects will be re-evaluated for eligibility at admission. Diarrhea will be defined as the passage of liquid feces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as having less than 3 bowel movements per week or as having fewer bowel movements than is usual for the subject

Exclusion at Admission:

  • Any significant change from screening which in the investigator's opinion would impact safety of subject or interfere with the evaluation of th study drug.
  • Had any acute illness within the past 2 weeks.
  • Consumed alcohol, grapefruit or grapefruit juice, orange juice, chocolate, or caffeine within 72 hours of dosing.
  • Used a bisphosphonate since screening.
  • Reported exposure to any known enzyme inducer or inhibitor, transport induceror inhibitor or nonmedical enzyme-inducers such as paint solvents or pesticides since screening.
  • A positive pregnancy test.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755872

Locations
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
Sponsors and Collaborators
Procter and Gamble
Sanofi-Aventis
Investigators
Study Director: William S Aronstein, MD, PhD Procter and Gamble
  More Information

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

Study placed in the following topic categories:
Calcium, Dietary
Risedronic acid

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 13, 2009