Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate

October 7, 2011 updated by: Warner Chilcott

Influence of a High-fat Meal on the Bioavailability of a Two Different Formulations of Risedronate

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Ft Myers, Florida, United States
        • Research Site
      • Miramar, Florida, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 the 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
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.
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.
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.
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.
Experimental: 2
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.
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.
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.
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.
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.
Experimental: 3
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.
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.
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.
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.
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.
Experimental: 4
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Director: William S Aronstein, MD, PhD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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